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

Model Number IPN028499

Device Problem Break (1069)

Patient Problems Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/24/2022

Event Type  Injury  

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 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
• Type of Device: 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
• MDR Text Key: 289538042
• Report Number: 3003898360-2022-00110
• Device Sequence Number: 1
• Product Code: HBO
• UDI-Device Identifier: 34026704631811
• UDI-Public: 34026704631811
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: IPN028499
• Device Catalogue Number: 658505
• Device Lot Number: 73A2100140
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/24/2022
• Initial Date FDA Received: 03/30/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention