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
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
- BD Luer-Lok 309657Becton, Dickinson And Company · Syringe, piston1,266 reports
- BD Luer-Lok 309653Becton, Dickinson And Company · Syringe, piston948 reports
- BD Luer-Lok 309628Becton, Dickinson And Company · Syringe, piston862 reports
- N/A 302995Becton, Dickinson And Company · Syringe, piston1 recall537 reports
- BD Plastipak Syringe 300865Becton, Dickinson And Company · Syringe, piston515 reports
- N/A 302830Becton, Dickinson And Company · Syringe, piston462 reports
- N/A 302832Becton, Dickinson And Company · Syringe, piston424 reports
- BD Ultra-Fine 328468Becton, Dickinson and Company Inc · Syringe, piston323 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.