McKesson 306616Recalls & reported problems

Summary

The FDA's MAUDE database contains 113 adverse event reports that list this exact device (DI 10612479262598), received between Jun 8, 2023 and Aug 26, 2026 — classified as 1 injury, 112 malfunctions.

The most frequently reported specific device problem is “Complete Blockage” (95 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 113 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 26, 2026Contamination /Decontamination Problem

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50459830 ↗
• MalfunctionMay 6, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB MCK NEEDLE PULLED OUT OF HUB. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. RECEIVED THE FOLLOWING PRODUCT COMPLAINT. THIS COMMUNICATION IS INTENDED FOR YOUR QUALITY ASSURANCE DEPARTMENT. THE PURPOSE OF THIS NOTIFICATION IS TO PROVIDE YOUR COMPANY WITH INFORMATION CONCERNING A CUSTOMER COMPLAINT SO THAT, IF NECESSARY, ACTION CAN BE TAKEN TO ENSURE THAT QUALITY STANDARDS ARE BEING MET. PLEASE INVESTIGATE AND PROVIDE, WITH THE OUTCOME/ CORRECTIVE ACTION FOR THE BELOW LISTED COMPLAINT. PLEASE SEND AN ACKNOWLEDGEMENT UPON RECEIPT OF THIS NOTIFICATION. ALL INVESTIGATION RESULTS AND RESPONSES SHOULD BE SENT TO IT IS OUR GOAL TO CLOSE ALL COMPLAINTS WITHIN 60 DAYS. COMPLAINT NUMBER (B)(4). REPORT DATE 4/20/2026 FACTORY/MANUFACTURER MFR REORDER # (B)(4). PRODUCT NAME NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6). PRODUCT CONCERN JUST GAVE A VACCINE WITH THE FOLLOWING NEEDLE ATTACHED, INJECTED ALL AS USUAL, WENT TO PULL IT FROM THE PATIENTS ARM AND THE NEEDLE CAME COMPLETELY OUT OF THE HOUSING, REMAINING IN THE ARM. SAMPLE AVAILABILITY PLEASE HAVE YOUR QA TEAM LOOK INTO THIS AND PROVIDE A WRITTEN RESPONSE REGARDING

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25101779 ↗
• MalfunctionMay 4, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB MCK NEEDLE PULLED OUT OF HUB. VERBATIM: COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. COMPLAINT NUMBER. DM-26-0228 REPORT DATE 4/14/2026 FACTORY/MANUFACTURER MFR REORDER (B)(4). PRODUCT NAME NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6). PRODUCT CONCERN MA WAS GIVING THE PATIENT A HPV SHOT, USING PREVENT SG SAFETY HYPODERMIC NEEDLE GLIDE. AFTER THE MA ADMINISTERED THE SHOT AND WENT TO REMOVE IT FROM THE PATIENT'S ARM, THE NEEDLE CAME DETACHED FROM THE HUB, AND THE NEEDLE WAS STUCK INTO THE PATIENT'S ARM. HOW WAS THE NEEDLE REMOVED? THE MEDICAL ASSISTANT WAS ABLE TO SAFELY REMOVE THE NEEDLE FROM THE PATIENT'S ARM. DID AN INJURY OCCUR? WHAT MEDICAL TREATMENT WAS PROVIDED FOLLOWING THE INCIDENT? NO INJURY OCCURRED; NO MEDICAL TREATMENT WAS NECESSARY. CUSTOMER NAME CUSTOMER CONTACT/EMAIL/PHONE CUSTOMER ADDRESS SAMPLE AVAILABILITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25070999 ↗
• MalfunctionMar 18, 2026Break

  THE FOLLOWING WAS PROVIDED BY THE INITIAL REPORTER: PRODUCT: 306616 - BD NEEDLE SFTYGLD 25X1 RB MCK - NEEDLE PULLED OUT OF HUB. UNIT OF MEASURE: QUANTITY: 1. LOT #: 5093367. PRODUCT PICK-UP INFO: ADDITIONAL DESCRIPTION NOTES: DONT SEND SAME AFFECTED LOT NUMBER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24628016 ↗
• MalfunctionJan 27, 2026Break; Material Integrity Problem

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB MCK NEEDLE PULLED OUT OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. WHEN ENGAGING SAFETY NEEDLE COVER AFTER ADMINISTERING VACCINE, NEEDLE POPPED OFF AND SCRATCHED NURSE IN THIGH.

  Patient problems: Needle Stick/Puncture

  MAUDE report 24188991 ↗
• MalfunctionJan 20, 2026Break

  IT WAS REPORTED THAT BD NEEDLE SFTYGLD 25X1 RB MCK NEEDLE PULLED OUT OF HUB. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THIS NEEDLE CAME DETACHED FROM THE LEUER LOCK AND WAS IN THE PATIENT'S ARM. (B)(6) 2026: ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. IT WAS UNCLEAR IF THE PATIENT RECEIVED THE FULL VACCINE OR NOT SINCE THE NEEDLE CAME OUT AND SOME FLUID LEAKED AFTERWARDS BUT IT WAS ASSUMED THAT THEY RECEIVED THE MAJORITY OF THE VACCINE. NO INJURY NOTED, RN REMOVED NEEDLE THAT WAS LEFT IN PATIENT'S ARM. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT DD-MMM-YYYY? 22-12-2025.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24117632 ↗
• MalfunctionJan 5, 2026Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X1 RB MCK NEEDLE PULLED OUT OF HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 306616, BATCH#: 5093369. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. SAFETY HYPODERMIC NEEDLE GLIDE 25G X 1IN. (LOT # 5093369) WHILE REMOVING THE NEEDLE AFTER ADMINISTERING THE INJECTION THE HUB BROKE OFF THE NEEDLE. THE NEEDLE HAD TO BE REMOVED SEPARATELY. ADDITIONAL INFORMATION PROVIDED: 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF THE EVENT IN FORMAT DD-MMM-YYYY? FRIDAY 12/12/2025. 2. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE TO SEND TO BD FOR INVESTIGATION? NO, WE DO NOT, WE DISCARDED EVERYTHING. WE JUST HAVE THE PICTURES THAT WERE INCLUDED. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO, NO HARM OR INJURY WERE HAPPENED. WHEN TAKING THE INJECTION OUT THE HUB BROKE OFF, AND THE NEEDLE STAYED IN THE PATIENT. WE WERE ABLE TO SUCCESSFUL REMOVE THE NEEDLE WITHOUT ANY HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23957586 ↗
• MalfunctionDec 31, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X1 RB MCK PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306616 BATCH # 5045756. RCC RECEIVED A COMPLAINT VIA EMAIL. AFTER ADMINISTERING THE INJECTION INTO THE DELTOID OF A PATIENT, THE MEDICAL ASSISTANT ATTEMPTED TO REMOVE THE NEEDLE FROM THE ARM TO PUT IT INTO SHARPS. THE NEEDLE BECAME DETACHED FROM THE LUER LOCK AND SAFETY, LEAVING THE NEEDLE IN THE PATIENTS ARM AND THE PREFILLED SYRINGE AND LUER LOCK PORTION OF THE SYRINGE INTACT. SHE WAS ABLE TO REMOVE THE NEEDLE FROM THE PATIENT. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EVENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23936956 ↗
• InjuryMay 22, 2025Break; Break

  IT WAS REPORTED THAT THE BD NEEDLE SFTYGLD 25X1 RB MCK WAS BROKEN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 306616. BATCH # UNKNOWN. VERBATIM: ACCOUNT GAVE AN HPV SHOT TO A YOUNG PATIENT OVER A YEAR AGO. THE PATIENT RECENTLY CAME BACK IN AND IT WAS DISCOVERED A NEEDLE IS IN THE PATIENTS ARM AND HAS BEEN WORKING ITS WAY DOWN THROUGH THE MUSCLE. THE ACCOUNT DOES NOT KNOW IF ITS THE NEEDLE FROM THE HPV SHOT OR WHEN THE INCIDENT OCCURRED, BUT THE ACCOUNT WOULD LIKE TO SPEAK TO SOMEONE AT BD REGARDING THE EVENT. CUSTOMER RESPONSE ON 13-MAY-2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? (B)(6) 2024. 2. CAN YOU PLEASE PROVIDE THE MATERIAL AND LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? PREVENT SG SAFETY HYPODERMIC NEEDLE GLIDE NON-PYROGENIC STERILE 25G X 1INCH. MFR: 192-N251S. I CANNOT CONFIRM THE LOT NUMBER DUE TIME THAT HAS PAST FROM THE EVENT. THE CURRENT LOT NUMBER WE HAVE IN STOCK IN CLINIC IS 0141231. 3. PLEASE DESCRIBE ANY ADDITIONAL, UNPLANNED MEDICAL OR SURGICAL INTERVENTION (E.G., ADDITIONAL/ALTERNATIVE MEDICATIONS, IMAGING, ETC.) REQUIRED TO AVOID PATIENT HARM. NEEDLE WAS DISCOVERED VIA AN XRAY RECENTLY DUE TO A SEPARATE, UNRELATED INJU

  Patient problems: Foreign Body In Patient

  MAUDE report 22074688 ↗
• MalfunctionMar 28, 2025Break; Break

  MATERIAL # 306616 BATCH # 5010901 IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED COMPLAINT NUMBER (B)(4). REPORT DATE - 03.11.25 MFR REORDER # (B)(4). PRODUCT NAME - NEEDLE, SFTY 192-N251S PREVENTS ORG 25GX1" LOT / SERIAL NUMBER - (B)(6). PRODUCT CONCERN - NEEDLE DETACHED/CAME OFF HUB WHILE IN THE PATIENT'S ARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21718702 ↗
• MalfunctionDec 8, 2024Complete Blockage; Complete Blockage

  MATERIAL # 306616, LOT # 2202914. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. VACCINE WOULD NOT ADVANCE IN NEEDLE. LOT NUMBER - 2202914. ADDITIONAL INFORMATION PROVIDED: 1) PLEASE PROVIDE DATE OF EVENT? 2)ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? 3). PLEASE SHARE THE CAPTURED PHOTO OF THE EVENT IF AVAILABLE. 4) ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. 1. 11/1/2024. 2. WE HAVE THE BOX OF NEEDLES, BUT THE USED NEEDLE WAS PLACED IN THE SHARPS CONTAINER AFTERWARDS. 3. I DO NOT HAVE A PHOTO OF THE INCIDENT OR THE NEEDLE. I DO HAVE A PHOTO OF THE BOX THE NEEDLE CAME FROM. 4. NO INJURY OR ADVERSE EVENT TO PATIENT OR HEALTHCARE PROFESSIONAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20875238 ↗
• MalfunctionAug 15, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19997075 ↗
• MalfunctionJun 9, 2024Complete Blockage; Complete Blockage

  MATERIALS#: (B)(4) , BATCH#: 2202914. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "VACCINE WOULD NOT PUSH THROUGH THE NEEDLES." PRODUCT DETAILS - NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT - 2202914. ADDITIONAL INFORMATION PROVIDED: ARE YOU ABLE TO PROVIDE THE DATES OF THE EVENTS IN THE FORMAT OF MM-DD-YYYY? IF UNKNOWN, CAN STATE UNKNOWN. THE DATE THE FAULTY NEEDLES WERE DISCOVERED WAS (B)(6) 2024. HOW WAS THE PATIENT OUTCOME? ARE THERE ANY CLINICAL SIGNS, HEALTH CONSEQUENCES OR IMPACT? THERE WERE NO HEALTH CONSEQUENCES TO ANY PATIENTS. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTH CARE PROFESSIONAL? NO ADVERSE EVENTS OR SERIOUS INJURIES OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495388 ↗
• MalfunctionJun 9, 2024Complete Blockage; Complete Blockage

  MATERIAL# 306616. BATCH# 3300424. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE NEEDLE PLUGS HALFWAY THROUGH GIVING AN INJECTION." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. COMPLAINT NUMBER (B)(4). REPORT DATE 5/24/24. FACTORY/MANUFACTURER BD. MFR REORDER # (B)(4). PRODUCT NAME NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6). PRODUCT CONCERN: THE NEEDLE PLUGS HALF WAY THROUGH GIVING AN INJECTION. ADDITIONAL INFORMATION PROVIDED 1. WHAT IS THE DATE OF EVENT? (B)(6) 2024. 2. PLEASE SHARE THE MATERIAL NUMBER. LOT NUMBER 3300424. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO HARM BUT THE NEEDLE BECAME PLUGGED HALFWAY THROUGH GIVING ANY INJECTION SO THE NEEDLE HAD TO BE CHANGED AND PATIENT THEN HAD TO BE REPOKED TO FINISH ADMINISTERING THE INJECTION. 4. ANY SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, ARE YOU ABLE TO PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NEEDLES WERE RETURNED TO OUR AMES PURCHASING DEPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19495360 ↗
• MalfunctionMay 14, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 19315675 ↗
• MalfunctionApr 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  MATERIAL#306616 BATCH# UNKNOWN. IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE PULLED OUT OF THE HUB. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "THE ENTIRE NEEDLE PULLED OUT OF THE HUB AND WAS LEFT INSIDE A INFANTS LEG." VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLE, SFTY 192-N231S PREVENTSG BLU 23GX1". THE ENTIRE NEEDLE PULLED OUT OF THE HUB AND WAS LEFT INSIDE A INFANTS LEG.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19164118 ↗
• MalfunctionApr 11, 2024Defective Component; Defective Component

  IT WAS REPORTED THAT THE BD SAFETYGLIDE SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT THE PRODUCT NEEDLE AND SAFETY MECHANISM IS FLIMSY. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. PRODUCT NEEDLE AND SAFETY MECHANISM IS FLIMSY. STAFF FEELS STRONGLY THESE WILL INCREASE CHANCES OF NEEDLE STICK WHEN TRYING TO INITIATE SAFETY. LOT#: 3292199 PRODUCT: NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19089580 ↗
• MalfunctionApr 9, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "I RECEIVED A COMPLAINT ON THE BELOW PRODUCT. WHEN THE NEEDLE IS LUERED ON, IT IS REQUIRING EXTREME PRESSURE TO PRIME OUT AIR IN NEEDLE. THERE APPEARS TO BE SOMETHING BLOCKING OR IN SYRINGE, POSSIBLY A SMALL PIECE OF PLASTIC. THIS HAS HAPPENED WITH MULTIPLE LOTS. PLEASE ADVISE WHAT WE SHOULD DO. IS THIS JUST A BAD LOT?" VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THERE APPEARS TO BE SOMETHING BLOCKING OR IN SYRINGE, POSSIBLY A SMALL PIECE OF PLASTIC. LOT#: 3300424. PRODUCT: NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19076284 ↗
• MalfunctionFeb 20, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18739253 ↗
• MalfunctionFeb 20, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER: "THE MEDICATION DOES NOT COME OUT OF THE NEEDLES. LIKE THEY ARE BLOCKED." COMPLAINT NUMBER (B)(4) REPORT DATE 1/23/2024 FACTORY/MANUFACTURER BD MFR REORDER # (B)(4) PRODUCT NAME NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6) PRODUCT CONCERN THE MEDICATION DOES NOT COME OUT OF THE NEEDLES. LIKE THEY ARE BLOCKED. CUSTOMER NAME (B)(6) CLINICS (B)(6) (B)(6) CUSTOMER CONTACT/EMAIL/PHONE (B)(6) CLINICS (B)(6) (B)(6)

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738981 ↗
• MalfunctionFeb 20, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS RECEIVED BY THE INITIAL REPORTER: "THE MEDICATION DOES NOT COME OUT OF THE NEEDLES. LIKE THEY ARE BLOCKED." COMPLAINT NUMBER (B)(4). REPORT DATE 1/23/24 FACTORY/MANUFACTURER BD MFR REORDER # 192-N251S PRODUCT NAME NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1" LOT / SERIAL NUMBER (B)(6). PRODUCT CONCERN THE MEDICATION DOES NOT COME OUT OF THE NEEDLES. LIKE THEY ARE BLOCKED. (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18738839 ↗
• MalfunctionFeb 1, 2024Complete Blockage; Complete Blockage

  NO ADDITIONAL INFORMATION

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628412 ↗
• MalfunctionFeb 1, 2024Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE USE THE MCKESSON 25GX1" SAFETY HYPODERMIC NEEDLES (#306616). WE'VE BEEN HAVING SOME ISSUES WITH THESE; WHEN INJECTING THE MEDICATION, IT'S AS THOUGH THE NEEDLE BECOMES BLOCKED. SOMETIMES WE INJECT 0.2ML BEFORE IT BLOCKS UP, SOMETIMES IT'S 0.5ML, THAT PART IS RANDOM. BUT WHEN THIS HAPPENS, WE HAVE TO POKE THE PATIENT A SECOND TIME. ANY RECOMMENDATION? HAVE YOU HEARD ABOUT THIS FROM ANYONE ELSE? I KNOW THIS IS THE 2ND OR 3RD BOX THAT WE'VE HAD THIS ISSUE WITH, SO I'M NOT SURE WHERE TO GO FROM HERE." ADDITIONAL INFORMATION RECEIVED ON 01/17/24: 1) MCKESSON SAFETY HYPODERMIC NEEDLES GLIDE, THIN WALL 25G X 1 IN MFR# 306616, LOT 3255801 *THERE WAS A PREVIOUS BOX ALSO, BUT WE WORKED OUR WAY THROUGH THAT ONE, SO I DO NOT HAVE THE LOT FROM THAT BOX. 2) I DO NOT HAVE AN EXACT DATE OF WHEN THIS OCCURRED. IT'S BEEN HAPPENING OVER THE LAST MONTH, EXCEPT IT DID HAPPEN TO (B)(6) YESTERDAY, (B)(6) 2024. 3) WE DO NOT HAVE A "PHYSICAL SAMPLE" AVAILABLE. DUE TO THIS BEING A NEEDLE, IT'S DISPOSED INTO A BIOHAZARD CONTAINER. IF WE NEED TO KEEP A NEEDLE, YOU WILL NEED T

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18628410 ↗
• MalfunctionJan 31, 2024Complete Blockage; Complete Blockage

  MATERIAL#: 306616, LOT#: 2188470. IT WAS REPORTED BY THE CUSTOMER REPORTED THAT NEEDLES WILL NOT ALLOW VACCINE TO BE PUSHED THRU THEM. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. NEEDLES WILL NOT ALLOW VACCINE TO BE PUSHED THRU THEM. 192-N251S. PRODUCT NAME: NEEDLE, SFTY 192-N251S PREVENTSG ORG 25GX1". COMPLAINT NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18613833 ↗
• MalfunctionDec 27, 2023Complete Blockage; Complete Blockage

  IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLE WAS CLOGGED/BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "NO INJURIES REPORTED. CUSTOMER STATES SOME OF THE NEEDLES DO NOT HAVE ANY HOLES. THEY ARE SOLID." PRODUCT#: 306616. LOT#: 2202914.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18405924 ↗

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