MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF JL 3.5 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534518T

Device Problem Crack (1135)

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

Event Date 10/08/2022

Event Type  malfunction  

Manufacturer Narrative

A review of the manufacturing documentation associated with lot 18116200 presented no issues during the manufacturing process that can be related to the reported event.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

As reported, at the end of the anti torque section of the 5f infiniti judkins left 3.5 100cm catheter there was a small vertical crack.The device was not used in a patient.There was no reported patient injury.The product's outer packing box and the outer packing was intact without any damage.The product was stored and handled according to the instructions for use (ifu).There was anomalies noted when removed from the package.The device will be returned for evaluation.

Manufacturer Narrative

This device is available for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.Additional information is pending and will be submitted within 30 days upon receipt.

Manufacturer Narrative

After further review of additional information received the following sections have been updated accordingly: g3, g6, h1, h2, h3, h6, and h10.Complaint conclusion: as reported, at the end of the anti-torque section of the 5f infiniti judkins left 3.5 100cm catheter there was a small vertical crack.The device was not used in a patient.There was no reported patient injury.The product's outer packing box and the outer packing was intact without any damage.The product was stored and handled according to the instructions for use (ifu).Anomalies were noted when it was removed from the package.One sterile cath f5 inf jl 3.5 100cm was received for analysis.Per visual analysis, the device was correctly packaged in the sterile pouch and no damage to the seal or bag surface was observed.The brite tip/distal tip, hub and body was observed and no damage was identified.A product history record (phr) review of lot 18116200 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The event reported by the customer as ¿brite tip/distal tip-cracked¿ was not confirmed.There is no evidence of damage to the device including the one specified in this complaint.Additionally, no evidence related to a manufacturing defect or anomaly was observed that could contribute to the event as reported.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, ¿to prevent damage to the catheter tip during removal from the package, grasp the hub and withdraw the catheter.¿ 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 F5 INF JL 3.5 100CM
• 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: 15716208
• MDR Text Key: 304612795
• Report Number: 9616099-2022-06078
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K970854
• 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,Followup
• Report Date: 01/10/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 534518T
• Device Catalogue Number: 534518T
• Device Lot Number: 18116200
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/10/2022
• 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