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

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/18/2024

Event Type  Injury  

Manufacturer Narrative

Device not available.

Event 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.

• Brand Name: PEN NDL 32G 6MM 3B TW 100CT US
• Type of Device: Needle, hypodermic, single lumen
• Manufacturer (Section D): BECTON DICKNSON AND CO. - DUN LAOGHAIRE CO, IRELAND
• 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
• MDR Text Key: 338371720
• Report Number: 9616656-2024-05170
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903207497
• UDI-Public: 00382903207497
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/22/2024

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
• Device Operator: Lay User/Patient
• Device Model Number: 320749
• Device Lot Number: 2354682
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 02/26/2024
• Initial Date FDA Received: 03/22/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1