MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL BD¿ NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number	305122
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	02/02/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported while using bd¿ needle 5/8 in.Single use, sterile, 25 g the needle was broken.There was no report of patient impact.The following information was provided by the initial reporter: a broken syringe needle.
Additional Manufacturer Narrative
Date of event is unknown; awareness date has been used for this field.Investigation summary: it was reported a staff member was stuck by a broken needle.To aid in the investigation, one sample with the plastic shield, but no packaging blister, and two photos were provided for evaluation by our quality team.The needle is bent, and the tip is through the plastic shield.The two photos provided show the sample received.No other defects or imperfections were observed.This defect could occur during the recapping by the customer inducing the defect reported.A device history record review was completed for provided material number 305122, lot 1273662.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer is confirmed.

• Brand Name: BD¿ NEEDLE 5/8 IN. SINGLE USE, STERILE, 25 G
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16457731
• Report Number: 1911916-2023-00111
• Device Sequence Number: 17785145
• Product Code: FMI
• UDI-Device Identifier: 30382903051220
• UDI-Public: (01)30382903051220
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/14/2023

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: Other
• Device Model Number: 305122
• Device Catalogue Number: 305122
• Device Lot Number: 1273662
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/02/2023
• Initial Report FDA Received Date: 02/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/30/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown