MAUDE Adverse Event Report: CORDIS DE MEXICO CATH F5 INF PIG145 110CM 6SH; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Model Number 534552S

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

The products were not returned for analysis. a device history record (dhr) review could not be conducted as the sterile lot number was not provided.Additional information is pending and will be submitted within 30 days upon receipt.

Event Description

It was reported that there were two infiniti 5f pig tail catheters that separated above the hub joint inside the patient.The catheters were removed from the patient safely by pulling the external part of the catheter.There were no patient injuries.

Manufacturer Narrative

This mdr report will be unreported as this is a duplicate of mdr report 9616099-2017-01017.

• Brand Name: CATH F5 INF PIG145 110CM 6SH
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer (Section G): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• Manufacturer Contact: cecil navajas ; 14201 nw 60th avenue; miami lakes, FL 33014
• MDR Report Key: 6449399
• MDR Text Key: 71418330
• Report Number: 9616099-2017-01015
• Device Sequence Number: 1
• Product Code: DQO
• UDI-Device Identifier: 20705032013922
• UDI-Public: 20705032013922
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970854
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2017

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 Model Number: 534552S
• Device Catalogue Number: 534552S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 03/08/2017
• Initial Date Manufacturer Received: 03/08/2017
• Initial Date FDA Received: 03/31/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 04/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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