MAUDE Adverse Event Report: BERPU MEDICAL TECHNOLOGY CO. LTD BERPU SAFETY NEEDLE; SAFETY NEEDLE, 25G X 1 INCH

Model Number	BER255
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Mckesson medical-surgical, inc.Is the assembler of convenience kits that include a needle component.The complaint reporter indicated that the needles were supplied in kit item # (b)(4): adult (pfz) ancillary 300 dose master convenience kit.The primary device identifier (di) for this kit is (b)(4).The complaint reporter provided a photo of the unit of use packaging to confirm the manufacturer's product identification information, including the lot number.The needle manufacturer's lot number was confirmed as a lot number that has been used to assemble the kit item # reported.We have notified (b)(6).For awareness.
Event or Problem Description
On (b)(6) 2022, a user facility reported a complaint with the berpu safety needles, 25g x 1 inch, that were supplied in the covid vaccine ancillary convenience kits.Reporter indicated that the safety needles are very flimsy.Both the needle and the safety latch bend easily, which led to a needlestick injury on (b)(6) 2022 at one of their primary care locations.

• Brand Name: BERPU SAFETY NEEDLE
• Common Device Name: SAFETY NEEDLE, 25G X 1 INCH
• Manufacturer (Section D): BERPU MEDICAL TECHNOLOGY CO. LTD; no. 14 xingji road; yongxing street longwan distri; wenzhou cn-33, zhejiang 32500 0; CH 325000
• Manufacturer (Section G): MCKESSON MEDICAL-SURGICAL, INC.; 9954 mayland drive; richmond VA 23233
• Manufacturer Contact: jo ann silverthorne ; 9954 mayland drive; richmond, VA 23233 ; 8045532278
• MDR Report Key: 13562211
• Report Number: 3017540467-2022-00001
• Device Sequence Number: 4339723
• Product Code: FMI
• UDI-Device Identifier: 06949236204001
• UDI-Public: 06949236204001
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K180417
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/17/2022

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: Health Professional
• Device Expiration Date: 03/21/2026
• Device Model Number: BER255
• Device Catalogue Number: KC-BER255
• Device Lot Number: 210326
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2022
• Initial Report FDA Received Date: 02/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/26/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown