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

Model Number	534552S
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/28/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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.
Additional 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
• Common Device Name: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): CORDIS DE MEXICO; circuito int nte 1820; juarez 32575 ; MX 32575
• MDR Report Key: 6449399
• Report Number: 9616099-2017-01015
• Device Sequence Number: 13626719
• Product Code: DQO
• UDI-Device Identifier: 20705032013922
• UDI-Public: 20705032013922
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K970854
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Health Professional
• Device Model Number: 534552S
• Device Catalogue Number: 534552S
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/08/2017
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 03/08/2017
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/31/2017
• Supplement Report FDA Received Date: 04/14/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1