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BD SafetyGlide 305950Recalls & reported problems

Becton, Dickinson And Company · SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB · Class 2

Quick summary

This BD SafetyGlide syringe has a sliding safety shield meant to cover the needle after use. The 61 reports mostly describe that shield sticking or failing to slide, needles that leak or splash, cracked or breaking parts, and needles that feel blunt or clog during injection; a few mention rusty needles and labeling gaps. There are 2 injuries and no deaths, with 59 malfunctions. No recalls name this device.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
61
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 61 adverse event reports that list this exact device (DI 30382903059509), received between Oct 18, 2017 and May 14, 2026 — classified as 2 injuries, 59 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (12 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 3 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 1 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 1 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 2 reportsFeb 2025: 0 reportsMar 2025: 1 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 1 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520263
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Leak/Splash12
  • Break8
  • Defective Component4
  • Detachment Of Device Component4
  • Device Markings/Labelling Problem4
  • Failure to Deliver4
  • Activation Problem3
  • Device Contamination with Chemical or Other Material3

Patient problems

  • No Clinical Signs, Symptoms or Conditions24
  • No Known Impact Or Consequence To Patient14
  • No Consequences Or Impact To Patient13
  • Insufficient Information5
  • Needle Stick/Puncture3
  • No Information2
  • No Patient Involvement1

Recent adverse event reports

The 25 most recent of 61 reports, in the reporter's own words as published by the FDA.

  • MalfunctionMay 14, 2026Mechanical Problem

    IT WAS REPORTED THAT BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. VERBATIM: COMPLAINT VIA PHONE. PIR ATTACHED CASE DESCRIPTION: SYRINGE ALRG SFTYGLD 1ML, THE SAFETY DEVICE ON IT DOES NOT SLIDE, DOES NOT GO FORWARD - CUSTOMER HAS 2 BOXES OF THESE AND WANTS TO KNOW WHAT COULD BE DONE. PRODUCT NAME: SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB PRODUCT OR REF#: (B)(4) LOT#: 5097080 THE EXACT DATE WAS WHEN THEY OPENED UP THE NEW PRODUCT. 4/23/26. THEY DID OPEN OTHER TRAYS IN BOTH CS¿S WITH SAME LOT # AND SAME PROBLEM WITH THE SAFETY PORTION NOT SLIDING DOWN. I¿LL HAVE THE CUSTOMER RETURN SOME TRAYS FOR YOU TO INVESTIGATE ETC. ONCE ITS NOTICED THAT IS DEFECTIVE, DO WE PICK UP THE ENTIRE PRODUCT AND SEND TO YOU FOR CREDIT BACK TO MCKESSON OR WILL 2CS BE SENT TO THE CUSTOMER DIRECTLY FREE OF CHARGE AS A REPLACEMENT? IS THERE WAS ANY HARM OR IMPACT TO THE PATIENT/HEALTH CARE PROVIDER. NO HARM JUST NEED THE CREDIT FOR 2 CS

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25173855 ↗
  • MalfunctionMar 17, 2026Activation Problem

    IT WAS REPORTED THAT BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB DEMONSTRATED A SAFETY MECHANISM FAILURE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. I WOULD LIKE TO REPORT A PRODUCT COMPLAINT. PRODUCT SAFETY FEATURE NOT WORKING. PO# (B)(4) MFR# (B)(4) LOT# 4345154 CASE NUMBER: (B)(4) (FOR (B)(4) EMPLOYEE CASE ACCESS): (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24617971 ↗
  • MalfunctionSep 9, 2025Activation Problem; Activation Problem

    IT WAS REPORTED THAT THE BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB SAFETY MECHANISM WAS DIFFICULT TO ACTIVATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305950 LOT # UNKNOWN. IS THE MANAGER FOR 19 LOCATIONS. THEY HAVE RECENTLY BEEN HAVING AN INCREASE IN NSI -NEEDLESTICK INJURIES, MANY DUE TO THE SAFETY OF THE NEEDLE NOT SLIDING/GLIDING CORRECTLY. WE ARE GOING TO ESTABLISH A WAY TO DOCUMENT HOW MANY ARE AFFECTED MOVING FORWARD - FAA HR COULD BE USED TO DOCUMENT PREVALENCE OF NSI FROM PAST MONTHS.

    Patient problems: Needle Stick/Puncture

    MAUDE report 23009013 ↗
  • MalfunctionMar 17, 2025Material Protrusion/Extrusion; Activation Problem; Material Protrusion/Extrusion; Activation Problem

    VIDEO RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21619973 ↗
  • MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

    MATERIAL # 305950. BATCH # 3341038, 4066070. IT WAS REPORTED THAT THE BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT BD SAFETY GLIDE DREW UP VERY SLOW, FELT PRESSURIZED WHEN INJECTING, THE NEEDLE FELT BLUNT, VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THEY ARE THE BD SAFETY GLIDE 1 ML 27 G X 1/2. I HAVE 2 LOT NUMBERS. LOT#3341038: 4 DREW UP VERY SLOW (TRICKLES AT A TIME, TAKES FOREVER TO FILL), AND 2 OF THESE FELT PRESSURIZED WHEN INJECTING. WE ALSO HAD 2 WHERE THE PATIENTS COMMENTED ON HOW BLUNT THE NEEDLE FELT. LOT #4066070: 3 DREW UP SLOW AND WERE PRESSURIZED WHEN INJECTING. 1 I COULD NOT DRAW UP BECAUSE IT WAS GOING SO SLOW AND I COULD NOT GET THE AIR BUBBLE OUT OF THE TOP. THIS IS OUR CURRENT LOT. THIS MORNING I HAD A PATIENT THAT GOT 3 INJECTIONS. 2 OF THE 3 DID NOT DRAW UP WELL SO I ASKED HIM IF HE COULD FEEL A DIFFERENCE AND HE SAID YES. THE 2 THAT DID NOT DRAW UP WELL FELT TINGLY AND MORE PAINFUL WHEN INJECTING AND THE OTHER ONE FELT FINE. ITEM: 305950. QUANTITY AFFECTED: (B)(4). SERIAL/LOT NUMBER: (B)(6). (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21289084 ↗
  • MalfunctionJan 31, 2025Complete Blockage; Complete Blockage

    MATERIAL # 305950, BATCH # 3341038, 4066070. IT WAS REPORTED THAT THE BD SYRINGE ALRG SFTYGLD 1ML W/NDL 27X1/2 RB NEEDLE WAS CLOGGED / BLOCKED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT BD SAFETY GLIDE DREW UP VERY SLOW, FELT PRESSURIZED WHEN INJECTING, THE NEEDLE FELT BLUNT, VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. THEY ARE THE BD SAFETY GLIDE 1 ML 27 G X 1/2. I HAVE 2 LOT NUMBERS. LOT#3341038: 4 DREW UP VERY SLOW (TRICKLES AT A TIME, TAKES FOREVER TO FILL), AND 2 OF THESE FELT PRESSURIZED WHEN INJECTING. WE ALSO HAD 2 WHERE THE PATIENTS COMMENTED ON HOW BLUNT THE NEEDLE FELT. LOT #4066070: 3 DREW UP SLOW AND WERE PRESSURIZED WHEN INJECTING. 1 I COULD NOT DRAW UP BECAUSE IT WAS GOING SO SLOW AND I COULD NOT GET THE AIR BUBBLE OUT OF THE TOP. THIS IS OUR CURRENT LOT. THIS MORNING I HAD A PATIENT THAT GOT 3 INJECTIONS. 2 OF THE 3 DID NOT DRAW UP WELL SO I ASKED HIM IF HE COULD FEEL A DIFFERENCE AND HE SAID YES. THE 2 THAT DID NOT DRAW UP WELL FELT TINGLY AND MORE PAINFUL WHEN INJECTING AND THE OTHER ONE FELT FINE. ITEM: 305950, QUANTITY AFFECTED: (B)(4) EA. SERIAL/LOT NUMBER: (B)(6). PO : (B)(4).

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21289083 ↗
  • MalfunctionOct 8, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

    MATERIAL#: 305950 BATCH#: 3289428 IT WAS REPORTED THAT THE BD SAFETYGLIDE NEEDLES HAD RUST / CORROSION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED ISSUE - THREE PACKAGES WITH RUSTY NEEDLES ITEM - 305950 LOT - 3289428 PO#1: 23840404.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20403263 ↗
  • MalfunctionMay 3, 2024Defective Component; Defective Component

    SAMPLES RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19244127 ↗
  • MalfunctionFeb 28, 2024Packaging Problem; Packaging Problem

    SAMPLES RECEIVED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18799014 ↗
  • MalfunctionFeb 12, 2024Defective Component; Defective Component

    IMDRF CODES MUST BE UPDATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18692392 ↗
  • MalfunctionFeb 12, 2024Defective Component; Defective Component

    IMDRF CODES MUST BE UPDATED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18692390 ↗
  • MalfunctionSep 26, 2023Break; Break

    IT WAS REPORTED THAT 10 BD ALLERGY SYRINGE TRAYS WITH BD SAFETYGLIDE¿ NEEDLES HAD BROKEN SAFETY COVERS. THIS IS 3 OF 3 RELATED REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD MULTIPLE COMPLAINTS ABOUT BATCH 2283756. 1) THE SYRINGE WITH CATALOGUE NUMBER SYR-80394 WAS FAULTY AND DEFECTIVE, 2) THERE WAS AN INJURY AT THE CUSTOMERS WORKPLACE WITH PATIENTS. THIS DUE TO THE SYRINGES NOT BEING SHARP ENOUGH OR WAS NOT CUT PROPERLY. THE CUSTOMER STATED IT WAS THE ALLERGY TREATED SYRINGE. THE CUSTOMER ALSO STATED THAT THE LITTLE PIECE THAT HOLDS THE SAFETY GUARD/GLID WAS SLIDING AROUND BEFORE THEY WOULD BE ABLE TO MANUALLY PUSH THE LEVER, OR THE ITEM WOULD MOVE BEFORE PUSHING IT IN. 3) A TOTAL OF 10 NEEDLES WERE DISCARDED WITHOUT THE SAFETY COVER DUE TO IT BEING BROKEN AND THE SAFETY GLID NOT BEING ABLE TO CLOSE. SOMETHING WAS BLOCKING WHERE IT WAS SUPPOSED TO SLID. 4) THE CUSTOMER STATED THAT THE SYRINGE WOULD DRAW UP FINE BUT THEN STARTED TO FLY TO LOOSE."

    Patient problems: Insufficient Information

    MAUDE report 17815644 ↗
  • MalfunctionSep 26, 2023Break; Break

    IT WAS REPORTED THAT 10 BD ALLERGY SYRINGE TRAYS WITH BD SAFETY GLIDE¿ NEEDLES HAD BROKEN SAFETY COVERS. THIS IS 2 OF 3 RELATED REPORTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER HAD MULTIPLE COMPLAINTS ABOUT BATCH 2283756. 1) THE SYRINGE WITH CATALOGUE NUMBER SYR-80394 WAS FAULTY AND DEFECTIVE, 2) THERE WAS AN INJURY AT THE CUSTOMERS WORKPLACE WITH PATIENTS. THIS DUE TO THE SYRINGES NOT BEING SHARP ENOUGH OR WAS NOT CUT PROPERLY. THE CUSTOMER STATED IT WAS THE ALLERGY TREATED SYRINGE. THE CUSTOMER ALSO STATED THAT THE LITTLE PIECE THAT HOLDS THE SAFETY GUARD/GLID WAS SLIDING AROUND BEFORE THEY WOULD BE ABLE TO MANUALLY PUSH THE LEVER, OR THE ITEM WOULD MOVE BEFORE PUSHING IT IN. 3) A TOTAL OF 10 NEEDLES WERE DISCARDED WITHOUT THE SAFETY COVER DUE TO IT BEING BROKEN AND THE SAFETY GLID NOT BEING ABLE TO CLOSE. SOMETHING WAS BLOCKING WHERE IT WAS SUPPOSED TO SLID. 4) THE CUSTOMER STATED THAT THE SYRINGE WOULD DRAW UP FINE BUT THEN STARTED TO FLY TO LOOSE.

    Patient problems: Insufficient Information

    MAUDE report 17815643 ↗
  • MalfunctionSep 26, 2023Defective Component; Defective Component

    IT WAS REPORTED WHILE USING BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE THE SAFETY MECHANISM SPUN. THIS IS 1 OF 3 RELATED REPORTS. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 1) THE SYRINGE WITH CATALOGUE NUMBER SYR-80394 WAS FAULTY AND DEFECTIVE, 2) THERE WAS AN INJURY AT THE CUSTOMER'S WORKPLACE WITH PATIENTS. THIS WAS DUE TO THE SYRINGES NOT BEING SHARP ENOUGH OR WAS NOT CUT PROPERLY. THE CUSTOMER STATED IT WAS THE ALLERGY TREATED SYRINGE. THE CUSTOMER ALSO STATED THAT THE LITTLE PIECE THAT HOLDS THE SAFETY GUARD/GLID WAS SLIDING AROUND BEFORE THEY WOULD BE ABLE TO MANUALLY PUSH THE LEVER, OR THE ITEM WOULD MOVE BEFORE PUSHING IT IN. 3) A TOTAL OF 10 NEEDLES WERE DISCARDED WITHOUT THE SAFETY COVER DUE TO IT BEING BROKEN AND THE SAFETY GLID NOT BEING ABLE TO CLOSE. SOMETHING WAS BLOCKING WHERE IT WAS SUPPOSED TO SLID. 4) THE CUSTOMER STATED THAT THE SYRINGE WOULD DRAW UP FINE BUT THEN STARTED TO FLY TO LOOSE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17815628 ↗
  • MalfunctionAug 23, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED WHILE USING BD SAFETYGLIDE¿ ALLERGY SYRINGE TRAY THERE WAS A MIXTURE OF PRODUCTS IN THE PACKAGE. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER SAID THAT SHE IS OPENING THE BD 5950 1.0CC 27G X 1/2"SG SYRINGES BOXES, AND, IN EACH BOX, THERE ARE A FEW U100 INSULIN SYRINGES 1ML /CC INSULIN SYRINGES. RIGHT NOW, IT HAS HAPPENED IN AT LEAST EVERY POUCH THEY HAVE OPENED. THERE WAS NO DOCUMENTATION IN THE COMPLAINT REGARDING PATIENT IMPACT. SO FAR, THE NURSES REMOVED THE INSULIN SYRINGES AND USED THE 27GX1/2 SG SYRINGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17605851 ↗
  • MalfunctionAug 18, 2023Loose or Intermittent Connection; Loose or Intermittent Connection

    IT WAS REPORTED THAT WHILE USING THE BD SAFETYGLIDE¿ THE SAFETY MECHANISM IS LOOSE. THE FOLLOWING WAS RECEIVED FROM THE INITIAL REPORTER: THERE IS A RAISED RUBBER PIECE THAT APPEARS TO HAVE COME LOOSE. IT SEEMS IT WOULD INTERFERE WITH GETTING AN ACCURATE DRAW/DOSE. IT IS WHITE IN COLOR NOT BLACK.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17580665 ↗
  • MalfunctionAug 15, 2023Packaging Problem; Packaging Problem

    IT WAS REPORTED THAT THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE EXPERIENCED MIXED PRODUCT TYPE IN A PACK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER STATED THEY RECEIVED BS SAFETY GUIDE AND FOUND BD U-100 INSULIN SYRINGES IN SOME OF THE PACKAGES.

    Patient problems: Insufficient Information

    MAUDE report 17553228 ↗
  • MalfunctionAug 15, 2023Volume Accuracy Problem; Volume Accuracy Problem

    IT WAS REPORTED THAT THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE EXPERIENCED SCALE MARKING ISSUES. WITH LOT NUMBERS 2304576 AND 2251991. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SOME WITHOUT NUMBERING SO FAR 15 OF THEM.

    Patient problems: Insufficient Information

    MAUDE report 17552458 ↗
  • MalfunctionAug 14, 2023Break; Break

    IT WAS REPORTED THAT THE SAFETY ON THE BD SAFETYGLIDE¿ ALLERGY TREATMENT SYRINGE TRAY'S BROKE. THE FOLLOWING WAS RECEIVED BY THE INITIAL REPORTER: CUSTOMER COMPLAINT ((B)(4) ): CUSTOMER SAID THAT THEY FOUND 2 BD INSULIN SYRINGES WITHIN THEIR SAFETY SYRINGE TRAYS. THIS IS THE 1ST COMPLAINT RECEIVED FROM A CUSTOMER FOR THE SAME ISSUE INVOLVING BATCH 2221315. AS ALK AND BD CURRENTLY HAVE NO QUALITY AGREEMENT IN PLEASE RESPOND TO THE COMPLAINT WITH YOUR INVESTIGATION RESULTS AS SOON AS POSSIBLE.

    Patient problems: Insufficient Information

    MAUDE report 17547183 ↗
  • MalfunctionAug 5, 2023Illegible Information; Illegible Information

    IT WAS REPORTED THAT UNSPECIFIED AMOUNT OF THE BD SAFETYGLIDE¿ ALLERGY TREATMENT SYRINGE TRAY SCALE MARKINGS WERE NOT ILLEGIBLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE ALSO HAVE SEVERAL THAT DON'T HAVE THE ML MARKERS PRINTED ON IT. THEY FADE AWAY THE FURTHER IT GOES. USUALLY DISAPPEARING COMPLETELY BY 0.5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17467061 ↗
  • MalfunctionAug 1, 2023Break; Break

    IT WAS REPORTED THAT DURING INJECTION WITH AN UNSPECIFIED AMOUNT OF BD SAFETYGLIDE¿ ALLERGY TREATMENT SYRINGE TRAY THE NEEDLES ARE BREAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WHEN THEY ARE TRYING TO PUT THE NEEDLES IN THE PATIENTS' ARMS, THE NEEDLES ARE BREAKING.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17435799 ↗
  • MalfunctionJun 16, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT 6 OF THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE EXPERIENCED MIXED PRODUCT TYPE IN A PACK. CUSTOMER CALLED AND STATED THAT 6 TRAYS HAVE INSULIN SYRINGES INSTEAD OF ALLERGY SYRINGES.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17148320 ↗
  • MalfunctionJun 6, 2023Break; Leak/Splash; Break; Leak/Splash

    IT WAS REPORTED THAT THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE PLUNGER BROKE OFF WHILE BEING PUSHED DURING THE INJECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "ON (B)(6) 2023 AN RN ATTEMPTED TO ADMINISTER A SUBCUTANEOUS INJECTION TO A PATIENT WITH BD SAFETYGLIDE 1ML 27G 1/2 IN ALLERGY SYRINGE. ONCE PLUNGER WAS PUSHED, THE PLUNGER BROKE OFF. RN NEEDED TO TAKE THE HALF BROKEN PLUNGER AND INSERT IT INTO THE BARREL OF THE SYRINGE IN ORDER TO CONTINUE TO ADMINISTER THE INJECTION, AS THE NEEDLE WAS STILL IN THE PATIENT'S ARM. DID YOU EXPERIENCE ANY ADVERSE EVENTS AS A RESULT OF THIS REPORTED DEFECT? THE INITIAL NOTIFICATION STATED THAT THE PLUNGER BROKE WHILE IN PATIENT ARM, WAS THERE ANY MEDICATION INTERVENTION REQUIRED DUE TO THE DEFECT? THE PATIENT RECEIVED THE COMPLETE DOSE OF MEDICATION AND LUCKILY DID NOT GET INJURED. NO OTHER INTERVENTION WAS REQUIRED".

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 17075531 ↗
  • MalfunctionMay 3, 2023Device Misassembled During Manufacturing /Shipping; Device Misassembled During Manufacturing /Shipping

    IT WAS REPORTED THAT INSULIN SYRINGES WERE FOUND MIXED IN WITH THE ALLERGY SYRINGES IN THE BD ALLERGY SYRINGE TRAY WITH BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER ORDERS FROM ALK, RECEIVED INSULIN SYRINGES WITH THE ALLERGY SYRINGES (MIXED PRODUCT) STATED THAT SOME ARE ALL ALLERGY (CORRECT) SOME WILL HAVE ALLERGY AND INSULIN SYRINGES."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16858186 ↗
  • MalfunctionMay 1, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

    IT WAS REPORTED THAT INSULIN SYRINGES WERE FOUND MIXED IN 2 BD ALLERGY SYRINGE TRAYS WITH BD SAFETYGLIDE¿ NEEDLE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "REPORTED ISSUE PER CUSTOMER: I WANTED TO LET YOU KNOW THAT IN THE LAST BATCH OF SYRINGES WE RECEIVED WE ARE NOTICING INSULIN SYRINGES MIXED IN WITH THE ALLERGY SYRINGES IN SOME OF THE TRAYS. NOT SURE WHAT¿S HAPPENING THERE."

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16841904 ↗

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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.