MAUDE Adverse Event Report: COOK, INC. TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Unraveled Material (1664)

Patient Problems No Consequences Or Impact To Patient (2199); Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 05/15/2015

Event Type  malfunction  

Event Description

The initial info stated that the wire unraveled.Add'l info received on (b)(6) 2015: right femoral and right internal jugular sites, at 17:15 and 18:00 delayed in medication administrations.An attempt was made to place the second line but this was unsuccessful; therefore the pt was transferred to icu.The doctor wasn't able to advance the guide wire enough to secure placement, as it would advance to a certain point and stop.During the attempt to retract the wire, it was caught on something; resulting in the wire unraveling in pt during retrieval.No pt injury occurred, and the wire and needle were retracted as one.Add'l info provided (b)(6) 2015: the delay in medication administration was due to the guide wire unraveling and the user being unable to establish central intravascular access.They did have peripheral lines, and were able to hydrate the pt and give appropriate medications, but the administration of some of these were delayed due to the staff trying to manage the central line.They have stated it is hard to say if the delayed establishment of a central line caused significant adverse events due to the pt condition and the multitude of variables.No add'l info has been provided regarding pt outcome.We will continue to monitor for similar complaints and have notified the appropriate personnel of this event.Insufficient risk due in.

Manufacturer Narrative

(b)(4).Event is still under investigation.

Manufacturer Narrative

(b)(4).Event evaluation: a review of complaint history, instructions for use (ifu), quality control, specifications, and a visual inspection of the returned device were conducted during the investigation.The product was returned in an open and damaged condition.Visual examination of the returned product finds that the mandrel and coil is broken approximately mid-point if overall length of wire; the mandrel is broken 29.5 cm from the apex of distal tip curve and the remaining section is 31 cm.The distal tip weld is intact.The coil has unraveled due to the break.The mandrel is broken off cleanly, inconsistent with a sharp bend causing the breakage nor does it appear to have been cut.The cause of the damage cannot be determined.There is no evidence to suggest the product was not manufactured to current specifications.Based on risk assessment, no further risk reduction activities are necessary at this time.

Event Description

The initial information stated that the wire unraveled.Additional information received on 01jun2015: right femoral and right internal jugular sites, at 17:15 and 18:00 delayed in medication administrations.An attempt was made to place the second line but this was unsuccessful; therefore the patient was transferred to icu.The doctor wasn't able to advance the guide wire enough to secure placement, as it would advance to a certain point and stop.During the attempt to retract the wire, it was caught on something; resulting in the wire unraveling in patient during retrieval.No patient injury occurred, and the wire and needle were retracted as one.Additional information provided 16june2015: the delay in medication administration was due to the guide wire unraveling and the user being unable to establish central intravascular access.They did have peripheral lines, and were able to hydrate the patient and give appropriate medications, but the administration of some of these were delayed due to the staff trying to manage the central line.They have stated it is hard to say if the delayed establishment of a central line caused significant adverse events due to the patient condition and the multitude of variables.No additional information has been provided regarding patient outcome.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK, INC.; bloomington IN 47404
• Manufacturer Contact: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 4861734
• MDR Text Key: 15129517
• Report Number: 1820334-2015-00401
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K081113
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,Distributor,company representati
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/21/2015

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: 08/18/2017
• Device Model Number: N/A
• Device Catalogue Number: C-UTLM-701J-RD-CAH
• Device Lot Number: NS5218556
• Other Device ID Number: SEE H10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/15/2015
• Device Age: 8 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/04/2014
• 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