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

Model Number	IPN005932
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Used in a cardiac case jaw broke off no harm to the patient, they used another one that was on hand.
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
Additional 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 or Problem 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
• Common Device Name: 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
• Report Number: 3011137372-2022-00145
• Device Sequence Number: 5948238
• Product Code: DWS
• UDI-Device Identifier: 24026704522129
• UDI-Public: 24026704522129
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/25/2022
• Supplement Date Received by Manufacturer: 09/02/2022
• Initial Report FDA Received Date: 08/03/2022
• Supplement Report FDA Received Date: 09/07/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• 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
• Patient Sex: Unknown