BD Ultra-Fine 320109Recalls & reported problems
Becton Dickinson Pen Limited · BD Ultra-Fine™ Pen Needles, 8mm 31G, 5bevel, TW · Class 2
Quick summary
This BD Ultra-Fine pen needle is a needle used for injections with insulin pens. Many of its 208 reports describe needles that clog or fail to deliver medication, and some describe needle parts breaking off, with some leaving fragments in the body. The reports include 14 injuries and no deaths. No recalls name this device. No reports came in the last 12 months, versus 21 in the 12 months before.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 229
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 229 adverse event reports that list this exact device (DI 00382903201099), received between May 11, 2018 and Sep 30, 2026 — classified as 14 injuries, 215 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (93 reports).
1 other recall cover devices cleared under the same FDA submission (K213478); they may or may not involve this specific model.
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
- Failure to Deliver93
- Break39
- Misconnection30
- Defective Device18
- Leak/Splash14
- Complete Blockage8
- Device Markings/Labelling Problem8
- Missing Information7
Patient problems
- No Clinical Signs, Symptoms or Conditions186
- Foreign Body In Patient15
- No Consequences Or Impact To Patient14
- Needle Stick/Puncture6
- No Known Impact Or Consequence To Patient5
- Insufficient Information3
- No Information2
- Bruise/Contusion1
Recent adverse event reports
The 25 most recent of 229 reports, 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 28, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917340 ↗MalfunctionSep 28, 2026Failure to Deliver
Consumer Reported finding 6 pen needles from this box that clogged during the flow check. Informed caller of the non patient end placement. DCLot # 4205051Catalog# 320109Date of EventSample Status Discard.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50917026 ↗MalfunctionSep 28, 2026Failure to Deliver
Consumer Reported finding 6 pen needles from this box that clogged during the flow check. Informed caller of the non patient end placement. DC.Lot # 4205051.Catalog# 320109.Date of Event.Sample Status Discard.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916882 ↗MalfunctionSep 28, 2026Failure to Deliver
Consumer Reported finding 6 pen needles from this box that clogged during the flow check. Informed caller of the non patient end placement. DCLot # 4205051Catalog# 320109Date of EventSample Status Discard
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916670 ↗MalfunctionSep 28, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50916483 ↗MalfunctionSep 26, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907942 ↗MalfunctionSep 26, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907930 ↗MalfunctionSep 26, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907919 ↗MalfunctionSep 26, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50907892 ↗MalfunctionSep 25, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50901616 ↗MalfunctionSep 25, 2026Failure to Deliver
Consumer Reported found 1 pen needle to clog during injection. tried injecting 4 times with this pen needle. Informed caller of non patient end placement and to complete a flow check with all injections Lot # 4030373Catalog# 320109Date of Event January 30 2025Sample Status discard----------------------------------------------------------------------------------This intake record was reviewed as part of CAPAs #PR-00078 and #PR-00080 and deficiencies were identified. The following actions were taken, Three additional complaint record was created for Needle Clog. With these actions completed, this Intake record is now consistent with applicable procedures CP62096, CP92021, and regulatory requirements, and separate complaints were opened for each separate event. There was appropriate follow-up (if this was required), and each event is addressed based on the most current information. No further action is required at this time unless new information becomes available.M. Samadi¿ 11- Sep- 2026
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50900088 ↗InjuryOct 15, 2025Break; Break
CONSUMER REPORTED THAT THE NEEDLE BROKE OFF IN HIS ABDOMEN WHILE DOING HIS INJECTION. HE STATED THAT HIS DOG JUMPED ON HIM WHILE HE WAS INJECTING, AND CAUSED THE NEEDLE TO BREAK OFF. CONSUMER STATED THAT HE WENT TO THE ER, AND THEY DID AN X-RAY, CT-SCAN, AND ULTRASOUND, BUT COULD NOT LOCATE THE NEEDLE. HE ALSO STATED THAT HE COULD FEEL THE NEEDLE POLKING HIS SKIN WHEN HE TOUCHES THE AREA. CONSUMER DOES NOT RE-USE. LOT #: 2277264. CATALOG #: 320109. DATE OF EVENT: UNKNOWN. SAMPLES: DISCARDED.
Patient problems: Foreign Body In Patient
MAUDE report 23299704 ↗MalfunctionSep 2, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED FINDING THE NEEDLES CLOG DURING THE INJECTION. CALLER DOES NOT COMPLETE A FLOW CHECK. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END TO PEN AND TO COMPLETE A FLOW CHECK. DC LOT # 4275005 CATALOG# 320109 DATE OF EVENT UNKNOWN SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22946287 ↗MalfunctionJun 13, 2025Failure to Deliver; Failure to Deliver
THE CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTIONS. STATED, SOMETIMES SHE GETS A CLOG WHEN PRIMING. LOT: 4177049, 4051832, 4128011, 4247011. CATALOG: 8MM PEN NEEDLES. DATE OF EVENT: UNKNOWN. SAMPLES: NO (B)(6).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22205195 ↗MalfunctionApr 28, 2025Failure to Deliver; Failure to Deliver
THE CONSUMER REPORTED PEN NEEDLE CLOG WHEN PRIMING HIS PEN NEEDLES. CONSUMER IS NEW TO INJECTIONS AND IS PRIMING THE 2 UNITS LIKE HE WAS TOLD. 12 PEN NEEDLES AFFECTED LOT: 4198054 CATALOG: 320109 DATE OF EVENT: UNKNOWN SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21918946 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K213478. One submission often covers many models, so check the product and lot details in each record.
- Z-3180-2026 · Jul 26, 2023 · Open, ClassifiedEWO_02513 (Catalog number 320122) For Investigational Use Only Nano Un-Cannulated Demo Samples Quantity 100
Other Needle, hypodermic, single lumen devices
- BD Nano 2nd Gen 320550Becton Dickinson Pen Limited · Needle, hypodermic, single lumen2,044 reports
- BD SafetyGlide 305916Becton, Dickinson And Company · Needle, hypodermic, single lumen1,767 reports
- BD Nano Ultra-Fine 320122Becton Dickinson Pen Limited · Needle, hypodermic, single lumen601 reports
- N/A 305106Becton, Dickinson And Company · Needle, hypodermic, single lumen1 recall467 reports
- N/A 305110Becton, Dickinson And Company · Needle, hypodermic, single lumen418 reports
- BD Safe-Clip 328235Becton, Dickinson and Company Inc · Needle, hypodermic, single lumen268 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
- BD Safety-Lok 305901Becton, Dickinson And Company · Needle, hypodermic, single lumen176 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.