BD Ultra-Fine 320749Recalls & reported problems
Becton, Dickinson And Company · BD Ultra-Fine Micro Pen Needles, 6mm, 32G, 3bevel, TW · Class 2
Quick summary
This BD Ultra-Fine Micro Pen Needle is a thin, short needle used with insulin pens. Most of the 42 reports describe needles that clog or fail to deliver insulin, needles that don't attach properly to the pen and bend, and loose or missing labels in the box. Two reports mention injuries. There are no recalls naming this device, and no reports were filed in the last 12 months compared with 10 in the prior 12 months.
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
- 48
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 48 adverse event reports that list this exact device (DI 00382903207497), received between Feb 1, 2022 and Sep 29, 2026 — classified as 2 injuries, 46 malfunctions.
The most frequently reported specific device problem is “Failure to Deliver” (25 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 Deliver25
- Complete Blockage7
- Defective Device4
- Misconnection4
- Break2
- Failure to Disconnect2
- Adverse Event Without Identified Device or Use Problem1
- Defective Component1
Patient problems
- No Clinical Signs, Symptoms or Conditions47
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 48 reports, in the reporter's own words as published by the FDA.
MalfunctionSep 29, 2026Failure to Deliver
Consumer Reported during the flow check finding the needle to clog. Informed caller of proper placement of Non patient end. DC .Lot # 4114084Catalog# 320749Date of Event 10.15.2024 = 3 pen needlesDate of Event 10.14.2024 = 5 pen needles. Sample 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; six additional complaint record were 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. (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929824 ↗MalfunctionSep 29, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929625 ↗MalfunctionSep 29, 2026Failure to Deliver
Consumer Reported during the flow check finding the needle to clog. Informed caller of proper placement of Non patient end. DC Lot # 4114084Catalog# 320749Date of Event 10.15.2024 = 3 pen needlesDate of Event 10.14.2024 = 5 pen needles. Sample 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; six additional complaint record were 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. (b)(6)2026.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929447 ↗MalfunctionSep 29, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929376 ↗MalfunctionSep 29, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929243 ↗MalfunctionSep 29, 2026Failure to Deliver
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50929017 ↗MalfunctionMay 23, 2025Failure to Deliver; Failure to Deliver
EMAIL: I HAVE HAD QUITE A FEW MALFORMED NEEDLES IN MY LAST ORDER OF FOUR BOXES 100 EA, REF 320743 LOT 4184028 MFG 2024-08-01 EXP-2029-07-31 (B)(4). I'M REQUESTING 1 REPLACEMENT BOX OR VOUCHER, THANK YOU. EMAIL SENT TO CONSUMER REQUESTING ADDITIONAL INFORMATION. LOT #: 4184028 CATALOG #: 320749 DATE OF EVENT: UNKNOWN SAMPLES: SENDING MAIL KIT. VCOYNE 30APRIL2025 UPDATE/ADDITIONAL INFORMATION FROM CUSTOMER CARE U.S. - "MY PREVIOUS EMAIL EXPLAINED THAT THEY WILL NOT ALLOW INSULIN TO PASS THROUGH THE NEEDLE AT THE BEGINNING OF THE INJECTION OR BECOMES OCCLUDED PART WAY THROUGH THE INJECTION I HAVE NOT SAVED ANY OF THE DEFECTIVE PRODUCTS BUT WILL IN THE FUTURE."
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22078152 ↗MalfunctionMay 12, 2025Failure to Deliver; Defective Device; Failure to Deliver; Defective Device
SPOUSE OF CONSUMER REPORTED NEEDLE CLOG DURING INJECTION. SHE STATED THAT THE DIAL WILL NOT DEPRESS. CONSUMER DOES NOT RE-USE. LOT #: 4163068. CATALOG #: 320749. DATE OF EVENT: UNKNOWN. SAMPLES: AVAILABLE - SENDING MAIL KIT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22004291 ↗MalfunctionMar 25, 2025Delivered as Unsterile Product; Delivered as Unsterile Product
CONSUMER REPORTED, "TEAR DROP LABELS" WERE NOT ATTACHED TO SOME PEN NEEDLES IN THE BOX BEFORE USE. CONSUMER DID NOT USE THE PEN NEEDLES THAT HE FOUND WITHOUT "TEAR DROP LABELS" ATTACHED. STATED, THE LABELS WERE LOOSE IN THE BOX. LOT: 4128060 CATALOG: 320749 DATE OF EVENT: UNKNOWN. SAMPLES: NO CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21693967 ↗MalfunctionJan 23, 2025Failure to Deliver; Failure to Deliver
CONSUMER REPORTED PEN NEEDLE CLOG WHEN TAKING INJECTIONS. STATED, SHE USED 3 PEN NEEDLES TO COMPLETE ONE INJECTION BECAUSE THE FLOW WOULD STOP. STATED, SHE DOES NOT PRIME BEFORE INJECTIONS. LOT: 3066051, CATALOG: 320749, DATE OF EVENT: 2024-30-12, SAMPLES: NO, CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21226097 ↗MalfunctionDec 3, 2024Misconnection; Misconnection
CONSUMER REPORTED WHEN PLACING THE NONPATIENT END ONTO THE PEN, THE NON-PATIENT END WILL NOT ATTACH PROPERLY AND BENDS THE NEEDLE ON THE INSIDE. INFORMED CALLER TO PLACE IT STRAIGHT ONTO PEN DC. LOT # 4093103, CATALOG# 320749, DATE OF EVENT UNKNOWN, SAMPLE STATUS AWAITING SAMPLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20832852 ↗MalfunctionNov 26, 2024Off-Label Use; Failure to Deliver; Off-Label Use; Failure to Deliver
CONSUMER REPORTED NEEDLE CLOG WHEN TRYING TO TAKE HIS INJECTION. STATED, HE DOES NOT TEST THE PEN NEEDLE BEFORE INJECTION. LOT: 3066051; CATALOG: 320749; DATE OF EVENT: UNKNOWN; SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20785812 ↗MalfunctionNov 22, 2024Failure to Deliver; Failure to Deliver
CONSUMER STATED, NO INSULIN FLOW WHEN TAKING INJECTION. STATED, SHE DOES NOT ALWAYS PRIME HER PEN NEEDLES BEFORE ATTEMPTING INJECTION. LOT: 2200719, CATALOG: 320749, DATE OF EVENT: UNKNOWN, SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20759474 ↗MalfunctionNov 7, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED DURING THE FLOW CHECK FINDING THE NEEDLE TO CLOG. INFORMED CALLER OF PROPER PLACEMENT OF NON PATIENT END. DC. LOT # 4114084, CATALOG# 320749. DATE OF EVENT 10.15.2024 = 3 PEN NEEDLES. DATE OF EVENT 10.14.2024 = 5 PEN NEEDLES. SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630798 ↗MalfunctionNov 7, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED DURING THE FLOW CHECK FINDING THE NEEDLE TO CLOG. INFORMED CALLER OF PROPER PLACEMENT OF NON-PATIENT END. DC. LOT#: 4114084, CATALOG#: 320749, DATE OF EVENT 10.15.2024 = 3 PEN NEEDLES, DATE OF EVENT 10.14.2024 = 5 PEN NEEDLES. SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20630761 ↗MalfunctionNov 6, 2024Misconnection; Misconnection
CONSUMER REPORTED THE NON PATIENT END WILL NOT ATTACH TO HER PEN. STATED, SHE HAS NEVER CHECKED THE NON PATIENT END TO SEE IF THE NEEDLE IS "BENT" OR "MISSING". CONSUMER DISCARDED THE PEN NEEDLES WITH THE ISSUE. ONLY HAS UNUSED SAMPLES CONSUMER REPORTED THE PROBLEM ON A PREVIOUS FILE, ((B)(4)). LOT: 3290795; CATALOG: 320749; DATE OF EVENT: UNKNOWN; SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20622066 ↗MalfunctionSep 30, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED FINDING THE PEN NEEDLE WOULD CLOG DURING THE FLOW CHECK. CONSUMER REPORTED FINDING THE PEN NEEDLE WOULD WORK DURING THE FLOW CHECK BUT CLOGGED DURING THE INJECTION. DC. LOT # 3325695; CATALOG# 320749; DATE OF EVENT UNKNOWN; SAMPLE STATUS DISCARD.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20332979 ↗MalfunctionJul 24, 2024Defective Device; Defective Device
CONSUMER STATED, WHEN HE REMOVES THE PEN NEEDLE AFTER HIS INJECTION, THE OUTER COVER SEPARATES FROM THE PEN NEEDLE INSTEAD OF STAYING TOGETHER. 35 PEN NEEDLES AFFECTED LOT: 3262745 CATALOG: 320749 DATE OF EVENT: UNKNOWN SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19817862 ↗MalfunctionJun 25, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED, INSULIN FLOW WILL STOP BEFORE INJECTION IS COMPLETE. STATED, HE ALWAYS PRIMES 2 UNITS BEFORE TAKING INJECTIONS. LOT: 3262745. CATALOG: 320749. DATE OF EVENT: UNKNOWN. SAMPLES: YES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19606336 ↗MalfunctionJun 21, 2024Leak/Splash; Leak/Splash
CONSUMER REPORTED LEAKAGE AT THE TIP OF THE NEEDLE, HE STATED THAT HE HELD THE NEEDLE IN PLACE FOR A FEW MINUTES AFTER THE INJECTION BUT WHEN HE REMOVED THE NEEDLE HE NOTICED DROPS OF INSULIN COMING FROM THE NEEDLE. CONSUMER IS CONCERNED THAT HE IS NOT GETTING HIS ENTIRE DOSE. CONSUMER DOES NOT RE-USE. LOT #: 3186904. CATALOG #: 320749. SAMPLES: DISCARDED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19585086 ↗MalfunctionJun 8, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED WHEN ATTEMPTING TO COMPLETE INJECTION LAST NIGHT, 3 PEN NEEDLES FAILED/CLOGGED DURING INJECTION. CALLER IS VISION IMPAIRED. INFORMED CALLER OF PROPER NON PATIENT END PLACEMENT AND TO COMPLETE FLOW CHECKS. LOT # 2354682. CATALOG# 320749. DATE OF EVENT (B)(6) 2024. SAMPLE STATUS DISCARD. CALLER DID NOT WANT TO LEAVE DEMOGRAPHIC INFORMATION.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19493332 ↗MalfunctionApr 17, 2024Misconnection; Misconnection
CONSUMER REPORTED ABOUT 25% PERCENT OF THE BOX DIFFICULT TO ATTACH THE NON PATIENT END TO THE PEN. LOT # 3136373. CATALOG# 320749. DATE OF EVENT UNKNOWN . SAMPLE STATUS DISCARD - DC.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19124648 ↗InjuryMar 22, 2024Break; Break
RETAIL PHARMACY REPORTED FOR HER PATIENT - PATIENT REPORTED AND RETURNED HER BOX OF PEN NEEDLES TO THIS PHARMACY. HAD 1 PEN NEEDLE THAT BROKE OFF IN CONSUMERS INJECTION SITE. CONSUMER WENT TO URGENT CARE. THE FACILITY COMPLETED AN XRAY AND DID NOT LOCATE THE NEEDLE IN SITE. NO FURTHER ATTENTION WAS INFORMED TO THIS PHARMACIST. DC LOT # 2354682 CATALOG# 320749 DATE OF EVENT 02/18/2024 SAMPLE STATUS UNUSED PRODUCT FROM THIS BOX. SAMPLE STATUS - NEEDLE BREAK WAS DISCARDED. CS0070101.
Patient problems: Foreign Body In Patient
MAUDE report 18960163 ↗MalfunctionMar 22, 2024Misconnection; Misconnection
CONSUMER REPORTED NON PATIENT END WOULD NOT ATTACH TO PEN. 1 PEN NEEDLE AFFECTED. LOT: 2271113. CATALOG: 320749. DATE OF EVENT: 2024-02-24. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18959833 ↗MalfunctionFeb 14, 2024Failure to Deliver; Failure to Deliver
CONSUMER REPORTED, NO INSULIN FLOW WHEN TAKING INJECTION. DOES NOT PRIME BEFORE INJECTION. LOT: 3073557. CATALOG: 320749. DATE OF EVENT: UNKNOWN. SAMPLES: YES CL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18705346 ↗
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.