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

Catalog Number C-TPNS-12.0D-90-REDO

Device Problems Break (1069); Detachment Of Device Component (1104); Kinked (1339); Split (2537)

Patient Problem No Information (3190)

Event Date 01/16/2015

Event Type  malfunction  

Manufacturer Narrative

This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.

Event Description

The information received indicated that the tip of the dilator was damaged during an insertion attempt.The reporter indicated that due to the extreme obesity of patient or curvature of vein and obstacle of clavicle, the appropriate twisting motion was used, at this point the introducer kinked and the tip of the dilator was damaged.Evaluation of the returned device indicated the dilator had been split beginning at the tip and extending 3mm proximally.The device had been split so that almost half the tip had detached at an angle, the second dilator had a 1mm split.A section of the device did not remain inside the patient¿s body.The procedure was completed with the use of a new set.According to the initial reporter the patient did not require any additional procedures due to this occurrence and the patient did not experience any adverse effects due to this event.

• Brand Name: REDO 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: larry pool ; 750 daniels way; bloomington, IN 47404 ; 8128294891
• MDR Report Key: 6764243
• MDR Text Key: 81911779
• Report Number: 1820334-2017-02220
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002080744
• UDI-Public: (01)00827002080744(17)170401(10)4882950
• Combination Product (y/n): N
• Reporter Country Code: CY
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/03/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C-TPNS-12.0D-90-REDO
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/02/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2014
• 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