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

Model Number	534521T
Medical Device Problem Codes	Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/22/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS CORPORATION; 14201 nw 60th avenue; miami lakes FL 33014
• MDR Report Key: 6995119
• Report Number: 9616099-2017-01543
• Device Sequence Number: 19128631
• Product Code: DQO
• UDI-Device Identifier: 20705032013694
• UDI-Public: 20705032013694
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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
• Distributor Facility Aware Date: 10/06/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/26/2017; 12/15/2017; 02/07/2018
• Initial Report FDA Received Date: 11/01/2017
• Supplement Report FDA Received Date: 11/05/2017; 12/29/2017; 02/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1