MAUDE Adverse Event Report: TELEFLEX MEDICAL CASTROVIEJO NH 8" TC; INSTRUMENTS, SURGICAL, CARDIO

Model Number IPN005932

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2022

Event Type  malfunction  

Event Description

Broken jaw.

Manufacturer Narrative

Qn#(b)(4).The device has not been returned for investigation.

Manufacturer Narrative

(b)(4).Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354965.(1) sample of 354965 lot j9 was received with a broken jaw.The fracture plane was inspected under magnification to determine that the failure was sudden and did not progress over time.The direction of the plane suggested that the jaws were overloaded parallel to the range of movement.This is consistent with use on oversized needles or tray damage.A dimensional inspection was not required as part of this investigation.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354965.The device is not functional in current state.The damage observed is consistent with overstressing the jaws in use or cleaning due to improper tray loading.

Event Description

Broken jaw.

• Brand Name: CASTROVIEJO NH 8" TC
• Type of Device: INSTRUMENTS, SURGICAL, CARDIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 3015 carrington mill blvd; morrisville NC 27560
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 15142065
• MDR Text Key: 304119589
• Report Number: 3011137372-2022-00160
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 24026704522129
• UDI-Public: 24026704522129
• Combination Product (y/n): N
• Reporter Country Code: RP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN005932
• Device Catalogue Number: 354965
• Device Lot Number: J9
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/18/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Treatment: N/A.