MAUDE Adverse Event Report: EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320551 / 320553 (BULK)
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Several pharmacy addresses from same pharmacy chain reported to embecta rep "the pen needles were received back into the inventory system with an incorrect expiry date.The date that was entered into the system was october 5, 2025 and the correct date that should have been entered was february 29, 2024 lot # unknown at this time catalog# unknown pen needle sample packets at this time date of event unknown.Sample status unknown.(b)(6) 10june2024 embecta was informed by our distributor (b)(4) that they received complaints from 18 customers regarding this event.This complaint covers one of the 18 complaints received by (b)(4).(b)(6) 10june2024: ¿to clarify, the expiry date labeled on the product is correct (feb 29, 2024).Due to manual error with entering the expiry date in the distributor system, the product was shipped past its labeled expiry.¿.
Additional Manufacturer Narrative
Additional information provided to sections b4, g6, h2, h3, and h11.Corrections made to section h6 (type of investigation & investigation conclusions).Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 18th 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.
Additional Manufacturer Narrative
Corrections made to section h6 (investigation findings & investigation conclusions).Investigation summary: additional information received, embecta was able to confirm this complaint and root cause was identified.A situation analysis was completed and capa opened to address the reported issue.This is the 15th of 18th 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.

• Brand Name: PN 32G 4MM HP 5 BAG 50 BOX SAMPLE US
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): EMBECTA PENEL LIMITED - DUN LAOGHAIRE, IRELAND
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 19505585
• Report Number: 3023359743-2024-00172
• Device Sequence Number: 6913733
• Product Code: FMI
• UDI-Device Identifier: 30382903205517
• UDI-Public: 30382903205517
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K212015
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/12/2024

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 Expiration Date: 02/29/2024
• Device Model Number: 320551 / 320553 (BULK)
• Device Lot Number: 9044773
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/27/2024; 09/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/20/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown