BD Ultra-Fine 320119Recalls & reported problems
Becton Dickinson Pen Limited · BD Ultra-Fine Pen Needles, 5mm, 31G, 5bevel, TW · Class 2
Quick summary
This BD Ultra-Fine pen needle is a thin needle used with insulin pens. Many of the 162 reports describe needles that clog or do not deliver insulin, will not attach properly to the pen, or are hard to remove after an injection. Of the reports, 154 are malfunctions and 8 describe injuries, with no deaths. No recalls name this device.
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
- 173
- Deaths reported
- 0
- Injuries reported
- 8
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 173 adverse event reports that list this exact device (DI 00382903201198), received between Oct 26, 2017 and Sep 30, 2026 — classified as 8 injuries, 165 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (81 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 Deliver81
- Misconnection19
- Break13
- Complete Blockage12
- Defective Device12
- Device Markings/Labelling Problem11
- Material Protrusion/Extrusion7
- Leak/Splash6
Patient problems
- No Clinical Signs, Symptoms or Conditions140
- No Consequences Or Impact To Patient17
- No Known Impact Or Consequence To Patient9
- Foreign Body In Patient4
- Hyperglycemia4
- Insufficient Information2
- Needle Stick/Puncture2
- Blister1
Recent adverse event reports
The 25 most recent of 173 reports, in the reporter's own words as published by the FDA.
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 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941577 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941576 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941573 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941572 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941571 ↗MalfunctionSep 30, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50941566 ↗MalfunctionJul 17, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED THE NEEDLE FROM LAST NIGHT CLOGGED DURING INJECTION. CALLER DOES NOT COMPLETE A FLOW CHECK. ADVISED CALLER HOW TO PROPERLY ATTACH NON PATIENT END TO PEN. LOT # 4268005 CATALOG# UNKNOWN, PEN NEEDLE, 5MM, MINI DATE OF EVENT 07.06.2025 SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22536039 ↗MalfunctionApr 21, 2025Failure to Deliver; Failure to Deliver
CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. HE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. LOT #: 3032929 CATALOG #: 320119 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21876762 ↗MalfunctionApr 21, 2025Misconnection; Defective Device; Misconnection; Defective Device
CONSUMER REPORTED THAT THE NEEDLES WILL NOT ATTACH AND THE NEEDLES ARE DIFFICULT TO REMOVE AFTER INJECTION. CONSUMER DOES NOT RE-USE. LOT #: 4107078 CATALOG #: 320119 DATE OF EVENT: UNKNOWN SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21872724 ↗MalfunctionApr 17, 2025Misconnection; Defective Device; Misconnection; Defective Device
CONSUMER REPORTED SOME PEN NEEDLES ARE HARD TO ATTACH OR CAN'T BE ATTACHED. STATED, PEN NEEDLES ARE HARD TO REMOVE AFTER INJECTIONS FOR THE ONES SHE CAN ATTACH LOT: 4093075. CATALOG: 320119. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21859366 ↗MalfunctionMar 25, 2025Misconnection; Misconnection
CONSUMER REPORTED FINDING 10-15 PEN NEEDLES FROM 2 BOXES THAT ARE HARD TO THREAD ONTO THE PEN PROPERLY. CAN'T USE THEM. INFORMED CALLER PROPER NON-PATIENT END PLACEMENT. (B)(6). LOT # 4051682 1 BOX. LOT # UNKNOWN = 1 BOX. CATALOG# 320119. DATE OF EVENT UNKNOWN. SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21688780 ↗MalfunctionMar 21, 2025Misconnection; Misconnection
CONSUMER REPORTED THAT THE NEEDLES WILL NOT ATTACH. SHE ALSO STATED THAT THE PATIENT END NEEDLE IS BENT. CONSUMER NOTICED IT AFTER INSPECTING THE NEEDLE WHEN IT WOULD NOT ATTACH. LOT #: 4184005. CATALOG #: 320119. DATE OF EVENT: 02-27-25. SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21664804 ↗MalfunctionFeb 11, 2025Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED DURING THE INJECTION THE NEEDLE CLOGS. CALLER DOES NOT PRIME THE NEEDLE. DC. LOT # 4086048, CATALOG# 32011, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21356071 ↗MalfunctionJan 2, 2025Failure to Deliver; Failure to Deliver
PHARMACIST REPORTED ISSUE ON BEHALF OF CONSUMER. STATED, NO INSULIN FLOW WHEN PRIMING PEN NEEDLES. STATED, THE CONSUMER IS USING THE ECHO PEN. PHARMACIST ASKED IF THE PEN NEEDLES ARE COMPATIBLE WITH THE ECHO PEN. I WAS ABLE TO ASSIST THE PHARMACIST WITH PRIMING TWO PEN NEEDLES WHILE ON THE CALL. LOT: 4107078, CATALOG: 320119, DATE OF EVENT: UNKNOWN, SAMPLES: YES (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21056233 ↗MalfunctionDec 31, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED NEEDLE CLOG DURING PRIMING. SHE STATED THAT THERE IS NO INSULIN FLOW. CONSUMER DOES NOT RE-USE. LOT #: 4093073, CATALOG #: 320119, DATE OF EVENT: UNKNOWN, SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21048236 ↗MalfunctionNov 18, 2024Failure to Deliver; Defective Device; Failure to Deliver; Defective Device
CONSUMER REPORTED WHEN USING THE PEN NEEDLES WITH HIS FLEXTOUCH PEN, THE NON PATIENT END NEEDLE WILL NOT ATTACH ONTO THE PEN NOR WILL IT PRESS OUT THE INSULIN. HAS TRIED SEVERAL PENS AND PEN NEEDLES FROM THIS BOX. DC CONSUMER REPORTED HAS NOT BEEN ABLE TO TAKE HIS INSULIN DUE TO THIS ISSUE. INFORMED CALLER OF NON PATIENT END PLACEMENT. HE FEELS THE NON PATIENT END IS STRAIGHT. BUT HE HAS VERY POOR VISION. LOT # 3297042. CATALOG# 320119. DATE OF EVENT UNKNOWN. SAMPLE STATUS AWAITING SAMPLES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20707547 ↗MalfunctionNov 12, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material
CONSUMER REPORTED, PRIOR TO INJECTION, CLEAR LIQUID CAME OUT OF THE PATIENT END AND WENT INTO HER PEN CAUSING THE INSULIN TO BECOME "CLOUDY". (B)(4) PEN NEEDLE AFFECTED STATED, AFTER HER INJECTION WITH A SECOND PEN NEEDLE FROM THE SAME BOX, SHE SAW A SMALL AMOUNT OF "BLOOD" IN HER INSULIN. NO INJURY TO REPORT. DID NOT SEEK MEDICAL INTERVENTION AND HER BLOOD SUGAR WAS NOT AFFECTED AFTER THE INJECTIONS. (B)(4) PEN NEEDLE AFFECTED. LOT: 4038407. CATALOG: 320119. DATE OF EVENT: 2024-17-10. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20669758 ↗MalfunctionOct 30, 2024Failure to Deliver; Failure to Deliver
FRI 9/27/2024 5:26 PM. SUBJECT: NOVOLOG FLEXPEN COMPATIBILITY. HELLO, I HAD BEEN USING THE HUMALOG FLEXPEN WITH BD ULTRA-FINE PEN NEEDLES MINI 5MMX1G FOR SOME TIME, BUT MY INSURANCE COMPANY RECENTLY STOPPED COVERING HUMALOG AND SWITCHED ME TO THE NOVOLOG FLEXPEN. A COUPLE OF MONTHS AGO, I RAN OUT OF HUMALOG AND STARTED USING NOVOLOG, BUT I'VE NOTICED THAT IT'S MUCH HARDER TO INJECT, AS THE MECHANISM ISN'T SMOOTH. I CONTACTED NOVOLOG, AND THEY INFORMED ME THAT THEY DON'T TEST FOR NEEDLES AND RECOMMENDED I PURCHASE NOVOLOG NEEDLES (NDC #0169-1851-89, 32G, 6MM). HOWEVER, I'M UNSURE WHETHER MY INSURANCE WILL COVER THEM OR IF MY PHARMACY WILL BE ABLE TO PROVIDE THEM. MY QUESTION FOR YOU IS: DO YOU TEST YOUR BD NEEDLES WITH NOVOLOG PRODUCTS? I'VE USED BD NEEDLES FOR YEARS WITH VARIOUS INSULIN PRODUCTS AND NEVER ENCOUNTERED THIS ISSUE BEFORE. I WOULD APPRECIATE YOUR GUIDANCE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20567965 ↗MalfunctionOct 24, 2024Misconnection; Off-Label Use; Failure to Deliver; Misconnection; Off-Label Use; Failure to Deliver
CONSUMER REPORTED NO INSULIN FLOW WHEN TAKING INJECTION STATED, HE HAS TO PUSH DOWN REALLY HARD WHEN TAKING HIS INJECTION. STATED, HE IS CONCERNED THE PEN NEEDLE MAY BREAK WHEN TAKING INJECTION. DOES NOT PRIME PEN NEEDLES BEFORE INJECTION. LOT: 4051681 CATALOG: 320119 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20526769 ↗MalfunctionOct 10, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED FOUND 2 PEN NEEDLES FROM THIS SUPPLY THAT CLOGGED DURING THE FLOW CHECK. DC. LOT #4044088. CATALOG# 320119. DATE OF EVENT 09.16.2024 = 1 PEN NEEDLE - AWAITING SAMPLE. DATE OF EVENT UNKNOWN = 1 PEN NEEDLE DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20417770 ↗
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 Ultra-Fine 320109Becton Dickinson Pen Limited · Needle, hypodermic, single lumen229 reports
- BD AutoShield Duo 329515Becton, Dickinson And Company · Needle, hypodermic, single lumen208 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.