MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland PEN NDL 32G 4MM PRO 100 BOX 1200 US; Needle, Hypodermic, Single Lumen

Model Number	320550
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Consumer reported found about 2 dozen pen needles from two different lot number.Unknown amount on each lot #.Needles would not prime.Noticed after removed from pen the non patient end needle to be bent.Dc lot # 3017179 lot # 3025239 catalog# unknown - 32g 4mm 2nd gen date of event unknown sample status awaiting sample.
Additional Manufacturer Narrative
Samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Embecta was not able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.This complaint record was reopened/opened and reviewed as part of capas #pr-00078 and #pr-00080.The review revealed that this complaint was determined to be a reportable event.The required activities for reporting this event were completed.The review confirmed that the complaint record is 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.There are no additional events or updates that meet the fda mdr reporting requirements.No further action is required at this time unless new information becomes available.(b)(6)2026.

• Brand Name: PEN NDL 32G 4MM PRO 100 BOX 1200 US
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, Ireland
• Manufacturer Contact: avital meri ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50943594
• Report Number: 3023359743-2026-00654
• Device Sequence Number: 10451910
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K212015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Type of Report: Initial
• Report Date (Section B): 09/30/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 320550
• Device Lot Number: Unknown
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/11/2024
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Patient Sequence Number: 1
• Patient Sex: Unknown