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

Catalog Number C-TPNS-3.0-65-REDO

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problems Swelling (2091); Reinfusion (2403); Surgical procedure, additional (2564)

Event Date 03/20/2015

Event Type  Injury  

Event Description

After connecting an infusion pump to a long term cvc line on (b)(6) 2015 on a (b)(6) female pt.The physician noticed swelling where the line is tunneled the next morning.The infusion went to the tissues.The physician took the line out and examined the catheter.There were no visible holes in the device when the catheter was flushed.It worked well with no signs of leakage.The physician then put a clamp at the tip of the catheter to close it and injected saline in the catheter.This time they saw that the saline coming out from 2 small holes on the catheter.The swelling has been absorbed.A section of the device did not remain inside the pt's body.The pt underwent general anesthesia for placement of another cvd line.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

(b)(4).This event is currently under investigation.

Manufacturer Narrative

A review of complaint history, device history record, instructions for use (ifu), quality control, and a visual inspection and functional test of the returned device were conducted during the investigation.Product was returned in an opened and used condition.A visual inspection noted that the device was relatively clean and free of biological matter.The lumen and 30 5cm of shaft were intact.Adequate adhesive was found on the proximal fittings.Functional testing confirmed a leak approximately 25 2cm distal of the strain relief/shaft joint.Whatever penetrated the material was small as to not be able to detect the leak with the naked eye.This product is shipped with an instructions for use pamphlet, which states warnings, precautions and suggested instructions for use.There is no evidence to suggest that the product was not manufactured to specification, and we are inconclusive as to why this failure mode occurred.The appropriate internal personnel have been notified and monitoring for similar complaints will continue.

• Brand Name: REDO SINGLE LUMEN TPN 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: lary pool, manager ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4713513
• MDR Text Key: 17691508
• Report Number: 1820334-2015-00224
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)170825(10)5192036
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,foreign,user facility
• Reporter Occupation: Unknown
• Type of Report: Initial,Followup
• Report Date: 03/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/25/2017
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: 5192036
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/14/2015
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 03/20/2015
• Device Age: 7 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 03/26/2015
• Initial Date FDA Received: 04/17/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 1 YR