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

Model Number 534518T

Device Problem Device-Device Incompatibility (2919)

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

Event Date 06/29/2021

Event Type  malfunction  

Manufacturer Narrative

Complaint conclusion: the 5f judkin¿s left (jl) 3.5 100cm infiniti catheter could not connect to the 3-way stopcock firmly.There was no reported patient injury.There was no damage to device package or device box.The product was stored properly according to the instructions for use (ifu).There was no reported difficulty removing the product from the packaging.There were no anomalies noted when the device was removed from the packaging.The two devices could not connect firmly.The product was not returned for analysis as it was discarded.A product history record (phr) review of lot 18002268 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.Based on the limited information provided, it is not possible to draw a clinical conclusion between the device and the reported event.Without the return of the device or images for analysis, the reported customer event ¿luer hub ¿ catheters, incompatibility/ fit¿ could not be confirmed, and the exact root cause could not be determined.Procedural/handling factors such as incorrect choice of ancillary devices and/or improper technique may have contributed to the reported event.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.Do not resterilize.Exposure to temperatures above 54°c (130°f) may damage the catheter.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.

Event Description

As reported, the 5f judkin¿s left (jl) 3.5 100cm infiniti catheter could not connect the 3-way stopcock firmly.There was no reported patient injury.There was no damage to device package or device box.The product was stored properly according to the instructions for use (ifu).There was no reported difficulty removing the product from the packaging.There were no anomalies noted when the device was removed from the packaging.The two devices could not connect firmly.The device will not be returned for evaluation as it was discarded.

• 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
• MDR Report Key: 12257844
• MDR Text Key: 264471157
• Report Number: 9616099-2021-04748
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 10705032013565
• UDI-Public: (01)10705032013565(17)240131(10)18002268
• Combination Product (y/n): N
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 08/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2024
• Device Model Number: 534518T
• Device Catalogue Number: 534518T
• Device Lot Number: 18002268
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/09/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/11/2021
• 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
• Treatment: UNK PRODUCT