MAUDE Adverse Event Report: TELEFLEX MEDICAL RANEY CLIPS DISPOSABLE; CLIP, SCALP

Model Number	IPN028499
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/24/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device history review for the product raney clips disposable lot# 73a2100140 investigation did not show issues related to the complaint.
Event or Problem Description
Failure description: when applying raney clip it broke into several pieces.2 large pieces were recovered and 1 small piece.However, there was 1 piece that was not found.The surgical field was searched as well as the floor of the or.The irrigation pouch was suctioned out as well.Event occurred when i was at an educational meeting so, this was relayed to me by another rn.Management was paged for further guidance.

• Brand Name: RANEY CLIPS DISPOSABLE
• Common Device Name: CLIP, SCALP
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; rancho el descanso; tecate 21478 ; MX 21478
• Manufacturer Contact: effie jefferson ; 3015 carrington mill blvd; morrisville 27560 ; 9194332672
• MDR Report Key: 13957539
• Report Number: 3003898360-2022-00110
• Device Sequence Number: 11849776
• Product Code: HBO
• UDI-Device Identifier: 34026704631811
• UDI-Public: 34026704631811
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/24/2022

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: Health Professional
• Device Expiration Date: 01/05/2026
• Device Model Number: IPN028499
• Device Catalogue Number: 658505
• Device Lot Number: 73A2100140
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2022
• Initial Report FDA Received Date: 03/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown