MAUDE Adverse Event Report: TELEFLEX MEDICAL CASTROVIEJO NH 7" TC; INSTRUMENTS, SURGICAL, CARDIO

Model Number	IPN005930
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Broken jaw, tip not aligned and not biting properly.
Event or Problem Description
Broken jaw, tip not aligned and not biting properly.
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 354964.(1) sample of 354964 lot g9 was received for evaluation.Visual review of the sample noted a cracked jaw.The cracked jaws was examined under magnification and stress fractures and rust were noted.The jaw is still attached with hairline cracks.The stress fractures on this and other samples indicate that a needle may have been used which was beyond the capacity of the device.The device is functions as expected with the exception of the broken jaw.Isolated and site specific.The samples provided include multiple lots and product codes which indicates that tray damage and oversized needles may have played a role in the observed damage.(1) sample of 354964 lot g9 was received for evaluation.Visual review of the sample noted a cracked jaw.The cracked jaws was examined under magnification and stress fractures and rust were noted.The jaw is still attached with hairline cracks.The stress fractures on this and other samples indicate that a needle may have been used which was beyond the capacity of the device.A dimensional inspection was not required as part of this investigation.The device is functions as expected with the exception of the broken jaw.Sap was reviewed for notifications pertaining to incoming inspection, stock checks, and product returns.No concerns were noted with reference to 354964 related complaints include 20038680, 20038604 and 20038603, 20038613, 20038642, 20038643, 20038644, 20038645, 20038646, 20038647 from a similar device.Isolated and site specific.The samples provided include multiple lots and product codes which indicates that tray damage and oversized needles may have played a role in the observed damage.

• Brand Name: CASTROVIEJO NH 7" TC
• Common Device Name: INSTRUMENTS, SURGICAL, CARDIO
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11602168
• Report Number: 3011137372-2021-00084
• Device Sequence Number: 14367475
• Product Code: DWS
• UDI-Device Identifier: 24026704522112
• UDI-Public: 24026704522112
• Combination Product (Y/N): N
• Initial Reporter Country: RP
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/18/2021

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: IPN005930
• Device Catalogue Number: 354964
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 05/19/2021
• Initial Report FDA Received Date: 04/01/2021
• Supplement Report FDA Received Date: 05/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1