BD Safety-Lok 305900Recalls & reported problems

Summary

The FDA's MAUDE database contains 31 adverse event reports that list this exact device (DI 00382903059003), received between Mar 27, 2018 and Jan 18, 2024 — classified as 1 injury, 30 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (5 reports).

4 other recalls cover devices cleared under the same FDA submission (K951254); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 31 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 18, 2024Complete Blockage; Complete Blockage

  MATERIALS#: 305900 BATCH#: 1160596 VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PROBLEM: 1. IT MAY BE VERY DIFFICULT TO PUSH MEDICATION THROUGH THE ABOVE LOT OF BD SAFETYGLIDE 22 G NEEDLES. 2. THE DEFECTIVE NEEDLES MAY CAUSE PATIENT AND ADMINISTRATOR DISCOMFORT. 3. THE FORCE REQUIRED TO ADMINISTER THE INJECTION MAY CAUSE MEDICATION LEAKAGE AND PATIENT INJURY. BD SAFETYGLIDE 25 G X 1-INCH NEEDLES: LOT =2025239 25 G X 1-INCH SAFETYGLIDE SHIELDING HYPODERMIC NEEDLES REF#(B)(4) LOT = REGN2117 SAFETYGUIDE SHIELDING HYPODERMIC NEEDLES REF# (B)(4) LOT=1160596 PER CUSTOMER RESPONSE 03JAN2024: IS THIS IN REGARD TO THE BD SAFETYGLIDE 25G X 1¿ NEEDLES? WE DO NOT CARRY THE 22G. I DID NOT PLACE A REPORT THAT IT WAS DIFFICULT TO PUSH A MEDICATION THROUGH. THERE WAS A RECALL ON SOME LOT NUMBERS OF BD SAFETYGLIDE 25G X 1¿ NEEDLES AND I REPORTED TO MY LOGISTICS TEAM THAT THOUGH I DID NOT HAVE THOSE SPECIFIC LOTS, I FELT THE NEEDLES AND SAFETY WERE FLIMSY ON THIS BRAND, WITH A POTENTIAL RISK FOR NEEDLE STICKS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18540105 ↗
• MalfunctionOct 30, 2023Defective Component; Defective Component

  NO ADDITIONAL INFORMATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18035960 ↗
• MalfunctionSep 15, 2023Defective Component; Defective Component

  IT WAS REPORTED THE THE BD SAFETYGLIDE¿ NEEDLE SAFETY MECHANISM FAILED. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER "THE SAFETY DEVICE ONLY CAME TO ABOUT HALF THE LENGTH OF THE NEEDLE¿.

  Patient problems: Insufficient Information

  MAUDE report 17761037 ↗
• InjuryMay 10, 2023Break; Break

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE BROKE AT THE HUB DURING USE AND THE DOCTOR NEED TO RETRIEVE IT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: DR. WAS INSERTING FREEZING INTO PATIENT'S TONSIL ABCESS USING A 22 1/12 INCH NEEDLE WHICH BROKE OFF AT THE HUB. DR WAS ABLE TO RETRIEVE AND DISCARD. PATIENT AWARE OF WHAT HAPPENED. PATIENT AWARE, NO ONE RECEIVED A NEEDLE STICK BUT POTENTIAL FOR HARM WAS THERE. WHO WAS AFFECTED? PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16900374 ↗
• MalfunctionMar 7, 2023No Flow; No Flow

  IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ SAFETY NEEDLES THE NEEDLE WAS CLOGGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCIDENT DETAILS: WHEN ATTEMPTING INTRAMUSCULAR INJECTION TO THE LEFT DELTOID, INCREASED PRESSURE WAS ENCOUNTERED AND THE INJECTION ATTEMPT HAD TO BE ABANDONED, DESPITE TROUBLESHOOTING NEEDLE POSITIONING, HUB CONNECTION, ETC. THE PATIENT HAD TO RECEIVE A SECOND INTRAMUSCULAR PUNCTURE WITH A NEW NEEDLE TO A DIFFERENT SITE. LATER TROUBLESHOOTING WITH A NEW SYRINGE (WATER FILLED) AND THE ORIGINAL NEEDLE (SAFETY ENGAGED, OVER APPROPRIATE RECEPTACLE) REVEALED THE SAME INITIAL ELEVATION IN PRESSURE THAT WAS ABLE TO BE OVERCOME WITH CONSIDERABLE FORCE. ANOTHER ATTEMPT WITH AIR FILLED SYRINGE REVEALED INCREASED PRESSURE, THOUGH ABLE TO EXPEL THE AIR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16496478 ↗
• MalfunctionMar 2, 2023Obstruction of Flow; Obstruction of Flow

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS ADDITIONAL BLOCKED NEEDLES. " THANK YOU! WE CONTINUE TO RECEIVE MORE BLOCKED NEEDLES. I HAVE A LARGE BAG FULL AND ADDING TO IT EVERY WEEK. JUST LET ME KNOW WHAT WE SHOULD BE DOING. THANK YOU".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16475465 ↗
• MalfunctionMay 5, 2022Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT WHILE USING A BD SAFETYGLIDE¿ SAFETY INJECTION NEEDLE, THE NEEDLE WAS CLOGGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PRIMARY RN WENT TO GIVE PT AN INJECTION AND THE 22G IM NEEDLE WOULD NOT PUSH. RN PULLED BACK UPON INITIAL INJECTION TO ENSURE I WAS IN THE RIGHT LOCATION WITHOUT PROBLEM. IM NEEDLE WOULDN'T PUSH. RN REMOVED NEEDLE CHANGED IT OUT WITH ANOTHER 22G AND HAD NO PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14290267 ↗
• MalfunctionApr 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE BD SAFETYGLIDE¿ NEEDLE PULLED OUT OF THE HUB WHILE INJECTING CORTISONE INTO THE SHOULDER JOINT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE BD NEEDLE HE WAS USING FOR A SHOULDER JOINT INJECTION DETACHED FROM THE NEEDLE HUB DURING ADMINISTRATION OF CORTISONE." "NEEDLE BECAME DETACHED FROM NEEDLE HUB WHILE PROVIDING SHOULDER INJECTION BY PHYSICIAN."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13977550 ↗
• MalfunctionMar 24, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED WHEN USING THE BD NEEDLE SFTYGLD 22X1-1/2 RB, THE USER IDENTIFIED THE NEEDLE PULLING LOOSE FROM THE HUB. THERE ARE NO REPORTS OF MEDICAL INTERVENTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED NEEDLE SEPARATED/BROKEN THE NEEDLE CAME AWAY FROM THE SYRINGE AND REMAINED IN THE PATIENT AFTER MEDICATION WAS ADMINISTERED.

  Patient problems: Foreign Body In Patient

  MAUDE report 13878250 ↗
• MalfunctionMar 24, 2022Material Separation; Material Separation

  IT WAS REPORTED WHEN USING THE BD SAFETYGLIDE¿, THE DEVICE EXPERIENCED NEEDLE SEPARATION FROM THE SYRINGE WHICH REMAINED IN THE PATIENT. THERE ARE NO REPORTS OF MEDICAL INTERVENTION NOTEDLY GIVEN TO THE PATIENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED THAT NEEDLE CAME AWAY FROM THE SYRINGE AND REMAINED IN THE PATIENT. NEEDLE CAME AWAY FROM THE SYRINGE AND REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13875589 ↗
• MalfunctionAug 17, 2021Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information; Defective Device; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED NEEDLE SFTYGLD 22X1-1/2 RB HAD A NEEDLE BREAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "A0203 - DEFECTIVE DEVICE A0501 - DETACHMENT OF DEVICE OR DEVICE COMPONENT".

  Patient problems: Foreign Body In Patient

  MAUDE report 12330788 ↗
• MalfunctionSep 30, 2020Leak/Splash; Failure to Deliver; Leak/Splash; Failure to Deliver

  IT WAS REPORTED THAT 2 NEEDLES SFTYGLD 22X1-1/2 RB HAD A PLUNGER THAT WAS DIFFICULT TO MOVE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE ADMINISTRATOR EXPERIENCED RESISTANCE WHEN PUSHING PLUNGER TO ADMINISTER MEDICATION FROM A NON BD SYRINGE. THE NEEDLE WAS CHANGED TO A 22G BD SAFETYGLIDE NEEDLE AND A DIFFERENT INSERTION SITE WAS SELECTED AND SAME RESISTANCE WAS MET UPON PUSHING DOWN ON THE PLUNGER. NURSE CLINICIAN ATTEMPTED A THIRD TIME WITH A 22G BD SAFETYGLIDE NEEDLE AND SAME RESISTANCE WAS MET AGAIN. EVENT DESCRIPTION STATES: INCIDENT DETAILS: UPON ADMINISTRATION OF SANDOSTATIN LAR MD 20MG INTRAMUSCULARLY TO PATIENTS RIGHT GLUTEAL REGION, WRITER MET RESISTANCE WHEN PUSHING PLUNGER DOWN TO ADMINISTER MEDICATION - NEEDLE REMOVED (19GAUGE X 1.5 INCH NEEDLE USED FROM SANDOSTATIN KIT) . WRITER CHANGED NEEDLE AND RE-ATTEMPTED INJECTION IM IN DIFFERENT SITE OF RIGHT GLUTEAL REGION WITH SAME RESISTANCE MET UPON PUSHING PLUNGER DOWN (22GAUGE X 1.5 INCH BD SAFETYGLIDE NEEDLE USED). NURSE CLINICIAN ATTEMPTED A THIRD TIME TO LEFT GLUTEAL REGION WITH ANOTHER NEW 22GAUGE X 1.5 INCH BD SAFETYGLIDE NEEDLE, SAME RESISTANCE MET ONCE AGAIN. WHEN NEEDL

  Patient problems: No Patient Involvement

  MAUDE report 10606279 ↗
• MalfunctionAug 17, 2020Tear, Rip or Hole in Device Packaging; Material Protrusion/Extrusion; Packaging Problem

  WHILE PREPARING THE OR FOR A SURGICAL PROCEDURE, THE SCRUB TECH FOUND A BD SAFETYGLIDE 22G X 1 1/2 HYPODERMIC NEEDLE IN ITS PACKAGING WITH NO PROTECTIVE COVER ON THE SHARP END WHICH WAS ALSO PROTRUDING OUT THE PLASTIC PACKAGING. THE SCRUB TECH WAS ABLE TO PREVENT THE DEVICE FROM REACHING THE SURGICAL TABLE AND ALSO FROM STABBING HERSELF DURING THE PROCESS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10413040 ↗
• MalfunctionApr 17, 2020Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB CAME WITH AN EXTRA NEEDLE THAT WAS STICKING OUT OF THE PACKAGE. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900 BATCH NO.: 9316337. IT WAS REPORTED THAT THE CUSTOMER HAD A SAFETY NEEDLE THAT HAD AN EXTRA UNPROTECTED NEEDLE IN THE PACKAGE AND IT WAS STICKING OUT THE SIDE OF THE PACKAGE. NOBODY WAS HURT.

  Patient problems: No Patient Involvement

  MAUDE report 9975221 ↗
• MalfunctionApr 2, 2020Difficult or Delayed Activation; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE NEEDLE SFTYGLD 22X1-1/2 RB WAS "FLIMSY" AND BENT DURING USE WHILE IN THE PATIENT'S KNEE, AND HAD TO BE REPLACED AS MEDICATION WOULDN'T DELIVER THROUGH IT. THE FLUID WAS STILL ABLE TO BE INJECTED INTO THE JOINT "WITH EFFORT". LOT#'S 9316337 AND AN UNSPECIFIED LOT WERE REPORTED TO HAVE BEEN INVOLVED IN THIS EVENT, BUT IT IS UNKNOWN HOW MANY OCCURRENCES HAPPENED WITHIN EACH. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 3 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I WOULD LIKE TO BRING UP A ZERO HARM SAFETY ISSUE WITH THE BD SAFETY GLIDE NEEDLES. WE HAVE USED THESE NEEDLES IN THE PAST FOR JOINT INJECTIONS AND HAVE HAD ISSUES WITH THEM. THE 22 GAUGE IS VERY FLIMSY AND MORE LIKE A 25-27 GAUGE. HERE IS AN EXAMPLE OF WHAT HAPPENED TODAY AND WHAT HAS HAPPENED IN THE PAST WHEN I'VE USED THEM. IT BENT AND CAME RIGHT OUT OF THE SAFETY WHEN I ENGAGED IT. I HAD ANOTHER TODAY WHICH BENT ABOUT 30 DEGREES WHEN ENGAGED THE SAFETY MECHANISM BUT DIDN'T COME OUT OF IT. I HAVE ALSO HAD THEM BEND WHILE IN A PATIENT'S KNEE AND HAD TO SWITCH THE NEEDLE BECAUSE YOU CAN'T INJECT THROUGH IT WHEN IT BENDS. IN FACT IT HAPPENED YESTERDAY AS WE

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9916736 ↗
• MalfunctionMar 3, 2020Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB CANNULA BROKE OFF FROM THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900 BATCH NO.: 7212757 IT WAS REPORTED THE NEEDLE BROKE OFF FROM THE HUB.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9779369 ↗
• MalfunctionFeb 21, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT NEEDLE WAS STICKING OUT OF PACKAGING AS CAP WAS NOT ON NEEDLE THUS AFFECTING STERILITY WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NURSE WENT TO USE THIS NEEDLE WHEN SHE NOTICED PART OF THE NEEDLE WAS STICKING OUT OF THE PACKAGING. IT APPEARS DURING THE ASSEMBLE PROCESS A CAP WAS NOT PUT ON THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9739105 ↗
• MalfunctionFeb 19, 2020Packaging Problem; Packaging Problem

  IT WAS REPORTED THAT THE NEEDLE SFTYGLD 22X1-1/2 RB WAS MISSING THE NEEDLE CAP AND STERILITY WAS COMPROMISED PRIOR TO USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: IT WAS REPORTED THAT THE NURSE WENT TO USE THIS NEEDLE WHEN SHE NOTICED PART OF THE NEEDLE WAS STICKING OUT OF THE PACKAGING. IT APPEARS DURING THE ASSEMBLE PROCESS A CAP WAS NOT PUT ON THE NEEDLE. NO ONE WAS STUCK OR INJURED BY THE NEEDLE. THE ATTACHED PICTURES OF AN NEEDLE WE RECEIVED. I WAS TOLD THE NURSE WENT TO USE THIS NEEDLE WHEN SHE NOTICED PART OF THE NEEDLE WAS STICKING OUT OF THE PACKAGING. IT APPEARS DURING THE ASSEMBLE PROCESS A CAP WAS NOT PUT ON THE NEEDLE. NO ONE WAS STUCK OR INJURED BY THE NEEDLE. I JUST WANT TO MAKE SURE THE TEAM IS AWARE IN CASE OTHER DEPARTMENTS HAVE FOUND A SIMILAR PROBLEM AND ARE AWARE OF THIS INCIDENT. I WILL SAVE THE NEEDLE IS A SAFE AND SECURE PLACE. PLEASE LET ME KNOW IF ANY OTHER DOCUMENTATION OR REPORTING NEEDS TO BE DONE BY OUR UNIT REGARDING THIS MATTER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727980 ↗
• MalfunctionFeb 19, 2020Leak/Splash; Difficult or Delayed Activation; Leak/Splash; Difficult or Delayed Activation

  IT WAS REPORTED THAT THE NEEDLE DID NOT RETRACT AND MEDICATION LEAKED OUT OF NEEDLE DURING USE WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THE RETRACTABLE SPRING DOES NOT RETRACT. IT WAS ALSO REPORTED THAT MEDICATION LEAKED OUT OF THE NEEDLE. PATIENT WAS INVOLVED BUT NO HARM OR ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9727857 ↗
• MalfunctionFeb 17, 2020Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB SAFETY MECHANISM FAILED TO ENGAGE. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900. BATCH NO.: 9316337. IT WAS REPORTED THE SAFETY MECHANISM FAILED TO ENGAGE AND WOULD ONLY ENGAGE HALF WAY. BROUGHT TO MY ATTENTION THAT BD SAFETYGLIDE NEEDLE FAILED TO SAFETY MECHANISM ENGAGE. 22# X 1 1/2 INCH CHECKED SIX OF THEM, AND HAD 50% OF THEM FAIL TO SPRING CLOSE. TOOK MULTIPLE ATTEMPTS TO GET THEM ENGAGE, AND SOMETIMES STARTED TO ENGAGE, BUT ONLY CLOSING HALF WAY, A DEFINITE SAFETY RISK FOR NEEDLE STICK. I TESTED OTHER GAUGES AND SIZES, AND DID NOT FIND ANY OTHER ISSUES.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9717273 ↗
• MalfunctionDec 17, 2019Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT PRIOR TO USE IT WAS DISCOVERED THAT THE NEEDLE DID NOT HAVE A CAP ON IT THUS AFFECTING STERILITY WITH A BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THE NEEDLE DID NOT HAVE A CAP.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9482327 ↗
• MalfunctionDec 10, 2019Material Protrusion/Extrusion; Material Protrusion/Extrusion

  IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB SAFETY DEVICE MALFUNCTIONED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO.: 305900 BATCH NO.: 9150905 IT WAS REPORTED THAT THE SAFETY DEVICE DID NOT DEPLOY AND MALFUNCTIONED AFTER INJECTION. PATIENT WAS IM'ED FOR AGITATION. WHEN GIVING INTRAMUSCULAR MEDICATION TO HIV PATIENT THE SAFETY DEVICE THAT IS SUPPOSED TO COVER THE NEEDLE WAS UNABLE TO DEPLOY/MALFUNCTIONED. NEEDLE CAREFULLY PULLED OUT OF PATIENT AND PROPERLY DISPOSED OF.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9445002 ↗
• MalfunctionDec 6, 2019Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT A NEEDLE CLOG OCCURRED DURING USE WITH A NEEDLE SFTYGLD 22X1-1/2 RB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "WHILE RN WAS ADMINISTERING AN IM MEDICATION USING THE 22G SAFETY GLIDE NEEDLE WHEN, HALF WAY THROUGH PUSHING THE MED, THE INFUSION STOPPED. THE RN RETRACTED THE NEEDLE SLIGHTLY AND TRIED A BIT MORE FORCE ON THE PLUNGER TO NO AVAIL. ONCE RN REMOVED NEEDLE FROM PATIENT, RN WAS STILL UNABLE TO ADVANCE THE MEDICATION THROUGH THE NEEDLE. THE RN SWITCHED NEEDLES AND WAS ABLE TO ADMINISTER THE REMAINDER OF THE DOSE, ALTHOUGH IT REQUIRED TWO INJECTIONS TO DO SO. UNCERTAIN AS TO WHETHER THIS WAS DUE TO NEEDLE MALFUNCTION OR "CLOT" IN THE MEDICATION (BETAMETHASONE) BEING ADMINISTERED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9428430 ↗
• MalfunctionNov 26, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT NEEDLE SFTYGLD 22X1-1/2 RB HAD CONNECTION ISSUES WHICH CAUSED LEAKED. THIS WAS DISCOVERED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 305900; BATCH NO. 8324528. IT WAS REPORTED UNABLE TO CONNECT CORRECTLY TO THE SYRINGE CAUSING MEDICATION TO LEAK OUT BETWEEN NEEDLE AND SYRINGE CONNECTION. DID NOT CONNECT CORRECTLY TO THE SYRINGE CAUSING MEDICATION TO LEAK OUT BETWEEN NEEDLE AND SYRINGE CONNECTION. USER CHECKED TO MAKE SURE IT WASN'T USER ERROR VS OTHER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9376755 ↗
• MalfunctionSep 5, 2019Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT (B)(4) OUT OF (B)(4) TOTAL NEEDLES SFTYGLD 22X1-1/2 RB WAS FOUND WITH FOREIGN MATTER IN IT BEFORE USE, DURING A VISUAL EVALUATION INSPECTION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 9TH OF 9 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "305900 -NDL, 22G X 1.5 SAFETY GLIDE- (B)(4) OUT OF (B)(4) FOUND TO HAVE LOOSE PARTICULATE." AS PART OF OUR CONTINUOUS IMPROVEMENT ACTIVITIES, THE MEDICAL FACILITY HAS UNDERTAKEN AN EXTENSIVE VISUAL EVALUATION OF INCOMING COMPONENTS TO CHARACTERIZE POSSIBLE SOURCE OF FOREIGN MATERIAL. THE TABLE BELOW HIGHLIGHTS THE RESULTS OF THAT INSPECTION. OVERALL, 6.4 % HAD SOME TYPE OF LOOSE PARTICULATE. TOTAL LOOSE: # INSPECTED PERCENTAGE: BD PART # INTERNAL AVID# DESCRIPTION 682 10589 6.4% 304134 500604 SYR, 10CC CONTROL L/L 6 52 11.5% 301073 500605 SYR, 3CC L/L 43 1581 2.7% 301031 500608 SYR, 20CC L/L 68 913 7.4% 301033 500609 SYR, 30CC L/L 95 788 12.1% 301035 500611 SYR, 60CC L/L 33 132 25.0% 301029 500620 SYR, 10CC L/L 433 7016 6.2% 303005 500640 NDL, 18G X 1.5" RG BEV 1 21 4.8% 381147 508408 ANGIOCATH 18G X 1.88" IV CATH 2 66 3.0% 305900 509337 NDL, 22G X 1.5 SAFETY GLIDE 1 20 5.0%

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8964673 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K951254. One submission often covers many models, so check the product and lot details in each record.

• Z-2889-2020 · Jul 28, 2020 · Terminated
  BD SafetyGlideTM 3ml 25G x 1 3mL SafetyGlide syringes, 50 units in pack
• Z-0315-2018 · Jul 5, 2017 · Terminated
  SafetyGlide Needle, 22GA 1-1/2in, Catalog n. 301701, manufactured by BD, sold in Centurion Convenience Kits. Centurion component code BD17O1NS.
• Z-3116-2017 · Jun 13, 2017 · Terminated
  BD Needle 22GA 1-1/2in SafetyGlide(TM) Non Sterile, Bulk, REF 301701 The BD SafetyGlide(TM) needle is intended to be used for general purpose injection, aspiration of fluids from
• Z-2748-2017 · Sep 16, 2016 · Terminated
  BD SafetyGlide" Injection Needle Catalog #305917 The SafetyGlide " needle is intended to be used for general purpose injection, aspiration of fluids from parts of the body below th