MAUDE Adverse Event Report: EMBECTA MEDICAL II LLC - PARSIPPANY, NJ PEN NDL 31GA 8MM 100 BX 1200 USA; Needle, Hypodermic, Single Lumen

Model Number	000000000000320109
Medical Device Problem Code	Misconnection (1399)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
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 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) 16-sep-2026.
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st 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.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

• Brand Name: PEN NDL 31GA 8MM 100 BX 1200 USA
• Common Device Name: Needle, Hypodermic, Single Lumen
• Manufacturer (Section D): EMBECTA MEDICAL II LLC - PARSIPPANY, NJ
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 50949429
• Report Number: 3022699058-2026-00014
• Device Sequence Number: 21439810
• Product Code: FMI
• UDI-Device Identifier: 00382903201099
• UDI-Public: 00382903201099
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• 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
• Operator of Device: Lay User/Patient
• Device Model Number: 000000000000320109
• Device Lot Number: 3312545
• Was Device Available for Evaluation?: No
• 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: 01/15/2025
• 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: Male
• Patient Race: Black Or African American