MAUDE Adverse Event Report: CORDIS CORPORATION CATH F5 INF JR 4 100CM; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534521T

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/22/2017

Event Type  malfunction  

Manufacturer Narrative

Device history record (dhr) review was conducted and the product met quality requirements for product acceptance.This device was received for analysis but the engineering report is not yet available.However, it will be submitted within 30 days upon receipt.

Event Description

It was reported that the f5 infiniti jr 4 100cm catheter was sealed and a strand of hair was noted when the device was being stocked in the cath lab.There was no patient injury.There were no damages noted to the packaging.The integrity of the sterile pouch was not compromised.The device will be returned for analysis.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that the f5 infiniti jr 4 100cm catheter was sealed and a strand of hair was noted when the device was being stocked in the cath lab.There was no patient injury.There were no damages noted to the packaging.The integrity of the sterile pouch was not compromised.One sterile unit of cath f5 inf jr 4 100cm was received in the original package folded in a plastic bag.Per visual analysis, a foreign material was observed in the pouch.No other anomalies were observed.An additional analysis was performed to identify chemical composition of foreign material.It could be concluded that foreign material found on f5 infiniti jr 4 100cm catheter has hair chemical composition since characteristic ir bands on spectrum obtained were observed.A device history record (dhr) review of lot 17671124 revealed no anomalies or non-conformances during the manufacturing and inspection processes that can be associated with the reported event.The reported ¿packaging/ pouch/box - foreign material - in sterile package¿ was confirmed through analysis of the returned device as foreign material was observed in the pouch.The exact cause of the foreign material could not be conclusively determined during analysis, however, ftir analysis suggests the foreign material has a hair-like chemical composition.As cautioned in the instructions for use, which is not intended as a mitigation, ¿do not use if package is open or damaged.Before use, flush all devices entering a blood vessel with sterile heparinized saline or a similar isotonic solution.¿ based on the product analysis, this reported event appears to be related to the manufacturing process of the product.A risk assessment to address this issue has been initiated.

• Brand Name: CATH F5 INF JR 4 100CM
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• Manufacturer (Section G): CORDIS CORPORATION; 14201 nw 60th ave; miami lakes FL 33014
• Manufacturer Contact: karla castro ; 14201 nw 60th ave; miami lakes, FL 33014
• MDR Report Key: 6995119
• MDR Text Key: 91222840
• Report Number: 9616099-2017-01543
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032013694
• UDI-Public: 20705032013694
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2018

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: 04/30/2020
• Device Model Number: 534521T
• Device Catalogue Number: 534521T
• Device Lot Number: 17671124
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 10/06/2017
• Initial Date Manufacturer Received: 10/06/2017
• Initial Date FDA Received: 11/01/2017
• Supplement Dates Manufacturer Received: 10/26/2017; 12/15/2017; 02/07/2018
• Supplement Dates FDA Received: 11/05/2017; 12/29/2017; 02/08/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/05/2017
• 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