MAUDE Adverse Event Report: BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND PEN NDL 32G 6MM 3B TW 100CT US; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	320749
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	02/18/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Device not available.
Event or Problem Description
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.
Additional Manufacturer Narrative
Additional information was added to: b4, g6, h2, h3, h11.Correction to d3 (country type, country), h6 (component code, investigation findings, investigation conclusions) investigation summary: samples were received and an investigation was performed.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.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.

• Brand Name: PEN NDL 32G 6MM 3B TW 100CT US
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND; EI
• Manufacturer (Section G): BECTON DICKINSON AND CO.; 1 becton drive; franklin lakes, NJ 07417
• Manufacturer Contact: avital merl ; 300 kimball dr.; parsippany, NJ 07054
• MDR Report Key: 18960163
• Report Number: 9616656-2024-05170
• Device Sequence Number: 15216520
• Product Code: FMI
• UDI-Device Identifier: 00382903207497
• UDI-Public: 00382903207497
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K213478
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 320749
• Device Lot Number: 2354682
• 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: 02/26/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/22/2024
• Supplement Report FDA Received Date: 06/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown