MAUDE Adverse Event Report: CORDIS CORPORATION CATH TEMPO 4F BER II 65CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 451415V0

Device Problem Crack (1135)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with this lot# 18022276 presented no issues during the manufacturing process that can be related to the reported complaint.This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

As reported, the physician noticed the catheter hub-end of the cath tempo 4f ber ii 65cm was fractured during initial usage after opening the packaging.The fractured catheter hub had reduced the ¿torque ability¿ of the catheter during usage.There was no reported patient injury.The device will be returned for evaluation.

Manufacturer Narrative

After further reviewed of additional information received the following sections have been updated accordingly : as reported, the physician noticed the catheter hub-end of the cath tempo 4f ber ii 65cm was fractured during initial usage after opening the packaging.The fractured catheter hub had reduced the ¿torque ability¿ of the catheter during usage.There was no reported patient injury.One non-sterile cath tempo 4f ber ii 65cm unit was receive for analysis.A cracked condition was noted on the luer hub during visual analysis.Sem analysis was performed and the broken area of the hub presented evidence of plastic deformation and fatigue striations.A product history record (phr) review of lot 18022276 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported event ¿luer hub - catheters ¿ cracked - during prep¿ was confirmed since a cracked condition was noted on the hub of the unit.Shipping, storage, or handling factors may have contributed to the reported event.Plastic deformation and fatigue striations found on the hub are commonly associated with separations caused by material tensile overload.Therefore, it is assumed that the hub was induced to a tensile force that exceeded the hub material yield strength prior to the crack.Users are trained to inspect for signs of damage prior to and during use.Any product with damage is not to be used.Information for safety is provided in the products labeling with the intent to make the user aware of the risks.According to the instructions for use (ifu), although not intended as a mitigation of risk, ¿store in a cool, dark, dry place.Do not use open or damaged packages.To prevent damage to the catheter tip during removal from the package, grasp the hub and gently withdraw the catheter.Treat all 4f catheters and smaller french sizes with ultimate care.The performance of these products may be impaired if not properly and cautiously handled during unpacking and preparation.¿ based on the information available and the phr review, there is no indication that the event is related to the device design or manufacturing process.Therefore, no preventative or corrective actions will be taken at this time.

• Brand Name: CATH TEMPO 4F BER II 65CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60 avenue; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60 avenue; miami lakes, FL 33014 ; 7863138372
• MDR Report Key: 13021542
• MDR Text Key: 290449791
• Report Number: 9616099-2021-05202
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032007877
• UDI-Public: (01)20705032007877(17)240430(10)18022276
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K973401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2022

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 Expiration Date: 04/30/2024
• Device Model Number: 451415V0
• Device Catalogue Number: 451415V0
• Device Lot Number: 18022276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2021
• Initial Date FDA Received: 12/16/2021
• Supplement Dates Manufacturer Received: 01/14/2022
• Supplement Dates FDA Received: 01/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/08/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1