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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 06/23/2022
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.
 
Event Description
Broken jaw.
 
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.
 
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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 Key15141826
MDR Text Key304717646
Report Number3011137372-2022-00156
Device Sequence Number1
Product Code DWS
UDI-Device Identifier24026704522129
UDI-Public24026704522129
Combination Product (y/n)N
Reporter Country CodeRP
Number of Events Reported1
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
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 NumberJ9
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? No
Initial Date Manufacturer Received 07/03/2022
Initial Date FDA Received08/01/2022
Supplement Dates Manufacturer Received08/18/2022
Supplement Dates FDA Received08/23/2022
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
Treatment
N/A.
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