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 07/22/2022

Event Type  malfunction  

Event Description

Used in a cardiac case jaw broke off no harm to the patient, they used another one that was on hand.

Manufacturer Narrative

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

Manufacturer Narrative

Qn#(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 (b)(4).1) sample of 354965 lot k9 was received with a broken jaw.The facture plane and location of the break is consistent with over stressing or tray damage and does not appear related to the device manufacturing.(1) sample of 354965 lot k9 was received with a broken jaw.The facture plane and location of the break is consistent with over stressing or tray damage and does not appear related to the device manufacturing.A dimensional inspection was not required as part of this investigation.A functional inspection was not required as part of this investigation.Multiple complaints have been received for this product code from a single customer implicating multiple lots- reference tcs 20043711, 20043712, 20043713, 20043714, 20043715, 20043716, 20043717, 20043718, 20043719, 20043720, 20043721.No manufacturing issues have been identified.The failures are combined across multiple lots (different years) of manufacturing and failing in tandem in site specific incidents.Device history record was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to (b)(4).Root cause not established.

Event Description

Used in a cardiac case jaw broke off no harm to the patient, they used another one that was on hand.

• 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: 15159391
• MDR Text Key: 304808095
• Report Number: 3011137372-2022-00145
• Device Sequence Number: 1
• Product Code: DWS
• UDI-Device Identifier: 24026704522129
• UDI-Public: 24026704522129
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/25/2022

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
• Device Operator: Health Professional
• Device Model Number: IPN005932
• Device Catalogue Number: 354965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 08/03/2022
• Supplement Dates Manufacturer Received: 09/02/2022
• Supplement Dates FDA Received: 09/07/2022
• 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