Insulin Syringe 3/10mL 30G x 8MM 328511Recalls & reported problems
Becton, Dickinson and Company Inc · SYRINGE 0.3ML 30GA 8MM 10BAG 500 · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00681131311724), received between Apr 26, 2019 and Jan 7, 2022 — classified as 3 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
- Leak/Splash1
Patient problems
- No Known Impact Or Consequence To Patient2
- 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.
MalfunctionJan 7, 2022Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED WHEN USING THE RELION SYRINGE, THE DEVICE EXPERIENCED NO LABEL OR MISSING LABEL INFORMATION OR ILLEGIBLE (ALL PACKAGING LEVELS). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: IT WAS REPORTED NO EXPIRATION DATE ON THE BOX. I RETURNED HCP' S CALL. SHE REQUESTED INFORMATION ON EXPIRATION DATE ON RELION SYRINGES. NO EXPIRATION DATE ON THE BOX.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13196779 ↗MalfunctionJun 1, 2020Device Markings/Labelling Problem; Device Markings/Labelling Problem
IT WAS REPORTED THAT SYRINGE 0.3ML 30GA 8MM 10BAG 500 WAL WAS MISSING LABEL INFORMATION. THIS WAS DISCOVERED BEFORE USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328511, BATCH NO. 6040778, 6172620. IT WAS REPORTED THAT EXPIRATION DATE IS MISSING FROM BOX.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 10107388 ↗MalfunctionApr 26, 2019Leak/Splash; Leak/Splash
IT WAS REPORTED THAT TWO SYRINGE 0.3ML 30GA 8MM 10BAG 500 WAL EXPERIENCED DIFFICULT PLUNGER MOVEMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL NO. 328511 BATCH NO. UNKNOWN. VERBATIM: RELION SYRINGE 3/10ML CC 30G 8MM PLUNGER STOPPER SEEMS TOO LARGE. ITS TIGHT AND HARD TO MOVE THE PLUNGER ROD. NOT SURE WHAT BOX OR BAG IT CAME FROM. FOUND 2 SYRINGES UNKNOWN LOT # UNKNOWN OCCD DATE.
Patient problems: No Known Impact Or Consequence To Patient
MAUDE report 8555287 ↗
Other Syringe, piston devices
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- 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 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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