MAUDE Adverse Event Report: COOK INC COOK TPN DOUBLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number N/A

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/16/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).The event is currently under investigation.A follow-up report will be submitted upon receipt of additional information or completion of the investigation.

Event Description

International customer reported that a cook total parenteral nutrition (tpn) double lumen catheter was implanted into a patient on (b)(6) 2016.The extension tubing of the catheter reportedly fractured on (b)(6) 2017 (1820334-2017-00680).The conditions and circumstances surrounding the event are not known.A kit was obtained to repair the device; the repair kit did not appear to be the proper size for the needed repair.( 1820334-2017-00771).A second repair kit was obtained and the catheter successfully repaired.The repaired catheter then fractured several hours later (1820334-2017-00772), and was subsequently explanted and replaced with a new tpn catheter on (b)(6) 2017.No further event or patient information was provided.The device was received for evaluation.This is one of three separate reports being submitted as three events were reported.See mdr numbers , 1820334-2017-00680, 1820334-2017-00771 and 1820334-2017-00772 for all associated events.The same patient is involved in all events.

Manufacturer Narrative

Investigation ¿ evaluation: a review of the complaint history, device history record, instructions for use (ifu), specifications, and a visual inspection of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed that the large lumen was severed 6.5 cm from the hub.The small lumen was severed 9.6 cm from the hub.4 mm of cannula protruded on the small lumen.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were two other reported complaints for this lot number.Based on the information provided, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK TPN DOUBLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 6489970
• MDR Text Key: 72796650
• Report Number: 1820334-2017-00680
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002018808
• UDI-Public: (01)00827002018808(17)190408(10)6878219
• Combination Product (y/n): N
• Reporter Country Code: AU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/10/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-TPNS-7.0D-65
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/30/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/08/2016
• 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
• Patient Age: 2 DA