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U.S. Department of Health and Human Services

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

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TELEFLEX MEDICAL CASTROVIEJO NH 8" TC; INSTRUMENTS, SURGICAL, CARDIO Back to Search Results
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.
 
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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 Key15159391
MDR Text Key304808095
Report Number3011137372-2022-00145
Device Sequence Number1
Product Code DWS
UDI-Device Identifier24026704522129
UDI-Public24026704522129
Combination Product (y/n)N
Reporter Country CodeAS
Number of Events Reported1
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 NumberIPN005932
Device Catalogue Number354965
Device Lot NumberUNKNOWN
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 Received08/03/2022
Supplement Dates Manufacturer Received09/02/2022
Supplement Dates FDA Received09/07/2022
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 Number1
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