BD Ultra-FineRecalls & reported problems across all models
Becton Dickinson Pen Limited · 4 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 460
- Deaths reported
- 0
- Injuries reported
- 26
- Recalls
- 0
We found 4 models of BD Ultra-Fine by Becton Dickinson Pen Limited in the FDA's device registry (GUDID). Together they are named in 460 adverse event reports in the FDA's MAUDE database, received between Oct 26, 2017 and Sep 30, 2026 — classified as 26 injuries, 434 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (191 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported BD Ultra-Fine problems
Device problems
- Failure to Deliver191
- Break62
- Misconnection54
- Defective Device32
- Device Markings/Labelling Problem29
- Leak/Splash23
- Complete Blockage21
- Missing Information10
Patient problems
- No Clinical Signs, Symptoms or Conditions353
- No Consequences Or Impact To Patient37
- No Known Impact Or Consequence To Patient30
- Foreign Body In Patient23
- Needle Stick/Puncture8
- Hyperglycemia6
- Insufficient Information5
- No Patient Involvement5
BD Ultra-Fine models
4 models, most reported first. Each model has its own page with its reports, recalls and device details.
- BD Ultra-Fine 320109Needle, hypodermic, single lumen229 reports
- BD Ultra-Fine 320119Needle, hypodermic, single lumen173 reports
- BD Ultra-Fine 328203Needle, hypodermic, single lumen56 reports
- BD Ultra-Fine 320881Needle, hypodermic, single lumen2 reports
Recent BD Ultra-Fine adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50950146 ↗MalfunctionSep 30, 2026Misconnection
Consumer Reported - Patient presented to clinic to report Pen Needles were Malfunctioning. He states he would pull the needle cap off and the needle was sticking in the cap. He tried to screw the needle on without success. He changed to a different box of pen needles and had no further problems per Patient he wasted approximately 12 needles that didn't work. Ref reports: MW5164028, MW5164029, MW5164030, MW5164031, MW5164032, MW5164033, MW5164034, MW5164035, MW5164036, MW5164037, MW5164038, MW5164039. Lot # 3312545.Catalog# unknown pen needle 31g 8mm.Date of Event (b)(6)2024.Sample Status discard.Initial reporter - Pharmacist.MDR report Key (b)(4).Date received 27-DEC-2024.MDR date entered 31-DEC-2024.-all 12 needles recorded on different MW report numbers. - See attached report. DC.____________________________________________This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken; eleven additional complaint records were created. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were op
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949429 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50949299 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948912 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948655 ↗MalfunctionSep 30, 2026Misconnection
Consumer Reported - Patient presented to clinic to report Pen Needles were Malfunctioning. He states he would pull the needle cap off and the needle was sticking in the cap. He tried to screw the needle on without success. He changed to a different box of pen needles and had no further problems per Patient he wasted approximately 12 needles that didn't work.Ref reports: MW5164028, MW5164029, MW5164030, MW5164031, MW5164032, MW5164033, MW5164034, MW5164035, MW5164036, MW5164037, MW5164038, MW5164039.Lot # 3312545.Catalog# unknown pen needle 31g 8mm.Date of Event (b)(6)2024.Sample Status discard.Initial reporter - Pharmacist.MDR report Key (b)(4).Date received 27-DEC-2024.MDR date entered 31-DEC-2024.-all 12 needles recorded on different MW report numbers.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50948158 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947814 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947566 ↗MalfunctionSep 30, 2026Misconnection
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50947414 ↗MalfunctionSep 30, 2026Misconnection
Consumer Reported - Patient presented to clinic to report Pen Needles were Malfunctioning. He states he would pull the needle cap off and the needle was sticking in the cap. He tried to screw the needle on without success. He changed to a different box of pen needles and had no further problems per Patient he wasted approximately 12 needles that didn't work.Ref reports: MW5164028, MW5164029, MW5164030, MW5164031, MW5164032, MW5164033, MW5164034, MW5164035, MW5164036, MW5164037, MW5164038, MW5164039.Lot # 3312545Catalog# unknown pen needle 31g 8mmDate of Event 25-NOV-2024Sample Status discardInitial reporter - PharmacistMDR report Key 21036023-Date received 27-DEC-2024MDR date entered 31-DEC-2024-all 12 needles recorded on different MW report numbers.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50945667 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer reported, no insulin flow when taking injection.12 pen needles affected.Stated, does not prime before attempting injection because she does not want to waste the medication.Stated, once, the patient end on the pen needle was missing prior to injection.Lot: 3304314Catalog: 320119Date of Event: UnknownSamples: No CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941586 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer reported, no insulin flow when taking injection.12 pen needles affected.Stated, does not prime before attempting injection because she does not want to waste the medication.Stated, once, the patient end on the pen needle was missing prior to injection.Lot: 3304314Catalog: 320119Date of Event: UnknownSamples: No CL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941585 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer reported, no insulin flow when taking injection.12 pen needles affected.Stated, does not prime before attempting injection because she does not want to waste the medication.Stated, once, the patient end on the pen needle was missing prior to injection.Lot: 3304314Catalog: 320119Date of Event: UnknownSamples: No CL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941582 ↗MalfunctionSep 30, 2026Failure to Deliver
Consumer reported, no insulin flow when taking injection.12 pen needles affected.Stated, does not prime before attempting injection because she does not want to waste the medication.Stated, once, the patient end on the pen needle was missing prior to injection.Lot: 3304314Catalog: 320119Date of Event: UnknownSamples: No CL
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941581 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941580 ↗
Other Becton Dickinson Pen Limited products
All Becton Dickinson Pen Limited devices →Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- 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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