Insulin Syringes, 1mL 29G x 1/2 328504Recalls & reported problems
Becton, Dickinson and Company Inc · SYRINGE 1.0ML 29GA 12.7MM 10BAG 500 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00681131311625), received between Nov 27, 2017 and Feb 25, 2021 — classified as 5 malfunctions.
The most frequently reported specific device problem is “Device Markings/Labelling Problem” (2 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Device Markings/Labelling Problem2
- Break1
- Component Missing1
- Device Contamination with Chemical or Other Material1
- Material Too Rigid or Stiff1
Patient problems
- No Known Impact Or Consequence To Patient3
- No Consequences Or Impact To Patient2
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionFeb 25, 2021Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF SYRINGE 1.0ML 29GA 12.7MM 10BAG 500 WAL HAD MISSING LABEL INFORMATION DURING USE. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT THE CONSUMER CALLED TO INQUIRE ABOUT THE EXPIRATION DATES ON THE SYRINGES. CONSUMER CALLED TO INQUIRE ABOUT EXPIRATION ON SYRINGES."
Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient
MAUDE report 11383150 ↗MalfunctionJun 2, 2020Device Markings/Labelling Problem
IT WAS REPORTED THAT SYRINGE 1.0ML 29GA 12.7MM 10BAG 500 WAL WAS MISSING AN EXPIRATION DATE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM BOX. VERBATIM: BD MAIL FULFILLMENT HAS SEVERAL BOXES WITHOUT EXP DATE INFO ON THE BOXES. INFORMED FULFILLMENT TO DESTROY THE BOXES AND NOT SEND THEM OUT TO THE CONSUMERS FOR REPLACEMENT. "
Patient problems: No Consequences Or Impact To Patient
MAUDE report 10113138 ↗MalfunctionOct 31, 2018Device Contamination with Chemical or Other Material
IT WAS REPORTED THAT A BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE HAD SOMETHING ORANGE ON THE NEEDLE TIP. THERE WAS NO REPORT OF EXPOSURE, SERIOUS INJURY, OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8025376 ↗MalfunctionApr 13, 2018Component Missing
IT WAS REPORTED THAT THE NEEDLE OF A BD MICRO-FINE¿ U-40 1ML, 29G X 12.7MM INSULIN SYRINGE WAS MISSING, AND THEN FOUND INSIDE THE BARREL OF THE SYRINGE. THERE WAS NO REPORT OF EXPOSURE, INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7429618 ↗MalfunctionNov 27, 2017Break; Material Too Rigid or Stiff
IT WAS REPORTED BEFORE USE OF THE BD MICRO-FINE" U-40 INSULIN SYRINGE THE CONSUMER STATED PLUNGER WAS SO TIGHT HE HAD TO PUSH AGAINST THE WALL TO USE. WHILE PUSHING THE PLUNGER, THE PLUNGER BROKE. THERE WAS NO REPORT OF INJURY OR MEDICAL INTERVENTION.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 7059770 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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