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BD Micro-Fine 329465Recalls & reported problems

Becton, Dickinson and Company Inc · BD Insulin Syringes with the BD Micro-Fine IV Needle, U-100, 12.7mm, 28G, 0.5mL · Class 2

Adverse event reports
3
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 30382903294658), received between Oct 16, 2020 and Jul 9, 2024 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Component Missing” (1 report).

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: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 0 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520261
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Component Missing1
  • Delivered as Unsterile Product1
  • Failure to Deliver1
  • Leak/Splash1
  • Off-Label Use1

Patient problems

  • Hyperglycemia1
  • Needle Stick/Puncture1
  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJul 9, 2024Leak/Splash; Off-Label Use; Leak/Splash; Off-Label Use

    MATERIAL # 329465. MATERIAL DESCRIPTION - SYRINGE 0.5ML 28GA 1/2IN 10BAG 500CAS. MATERIAL LOT# - 3289943. COMPLAINT DESCRIPTION: CALLER IS A LAB WORKING WITH MICE INJECTING SALINE INTO MOUSE. CALLER DREW IN SALINE INTO SYRINGE AND INJECTED THE MOUSE. THE MOUSE SUFFERED A EMBOLISM AND DIED. CALLER LOOKED AT THE TIP OF THE NEEDLE. THE BEVEL HAS AN EXTRA HOLE. FEELS AIR GOT INTO SALINE FROM THIS HOLE. CLAIMS SHE DID PRIME THE SYRINGE BEFORE INJECTION TO MAKE SURE NO AIR IN SYRINGE. DISCARDED THE SYRINGE. NOTE: WE HAVE ATTACHED THE ORIGINAL REQUEST THAT WE RECEIVED IN MAIL FOR FURTHER REFERENCE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19704550 ↗
  • MalfunctionOct 13, 2023Delivered as Unsterile Product; Component Missing; Delivered as Unsterile Product; Component Missing

    IT WAS REPORTED THAT 2 BD INSULIN SYRINGES WITH THE BD MICRO-FINE¿ IV NEEDLE HAD NO CAPS/CANNULA SHIELDS ON THEM. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "COMPLAINT: THE CAP HAS NOT BEEN ON THE INSULIN SYRINGE, THE MOST RECENT CASE RESULT IN A CLEAN NEEDLE STICK. THERE IS ALSO ANOTHER BAG WITH A SYRINGE WITH MISSING CAP."

    Patient problems: Needle Stick/Puncture

    MAUDE report 17933122 ↗
  • InjuryOct 16, 2020Failure to Deliver; Failure to Deliver

    IT WAS REPORTED THAT THE SYRINGE 0.5ML 28GA 1/2IN 10BAG 500CAS WAS UNABLE/DIFFICULT TO ASPIRATE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER'S SPOUSE CALLED TO INFORM OF AN INCIDENT WHERE THE CUSTOMER WAS UNABLE TO DRAW INSULIN INTO THE SYRINGE AND WAS UNAWARE THAT INSULIN COULD NOT BE DRAWN. AFTER DINNER, CUSTOMER CHECKED BLOOD GLUCOSE LEVELS TO GREATER THAT 300 MG/DL. THEY TRIED TO REDRAW WITH THE SYRINGE PREVIOUSLY USED AND DETERMINED IT WAS DRAWING INSULIN, WATER ON ANYTHING. SPOUSE OF CONSUMER STATED, HER HUSBAND IS DOING FINE NOW. STATED, HIS NUMBERS WENT DOWN TO NORMAL AND SHE DID NOT HAVE TO TAKE HIM TO A DOCTOR. STATED, HER HUSBAND WAS UNABLE TO DRAW INSULIN 1 SYRINGE AFFECTED.

    Patient problems: Hyperglycemia

    MAUDE report 10690600 ↗

Other Syringe, piston devices

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