MAUDE Adverse Event Report: COOK INC DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET ; FOZ CATHETER, INTRAVASCUALR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number PICDS-701-MPIS-NT

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Other (for use when an appropriate patient code cannot be identified) (2200)

Event Date 11/06/2014

Event Type  Injury  

Event Description

The (b)(6) female pt was brought down to the department and had picc line insertion.The pt had returned to floor when the nurse called and said the device was leaking, the pt was returned back down to the department where it was found that a small hole was in the tip of the yellow lumen.The initial picc line was removed and replaced with a new one.A section of the device did not remain inside the pt's body.According to the initial reporter, the pt did not experience any adverse effects due to this occurrence.

Manufacturer Narrative

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

Manufacturer Narrative

During the investigation, a review of complainant history, instructions for use (ifu), and quality control was conducted.Two opened and used devices were returned for investigation.Device 1: the extension tube was covered by adhesive tape, shaft length - 19.4 cm.Once the adhesive was removed the device was flushed and a pinhole was noted in the yellow extension ~ 1.3 cm under the hub.Device 2: injection caps were on both hubs, shaft length = 19.7 cm.Flushing of this catheter was unable to locate a leak whether the catheter was free flowing or pinched off.A 24.9 cm and a 24.5 cm of the shaft had been cut off and returned as well.This product is shipped with an ifu which states "warnings, precautions and instructions for use." there is no evidence to suggest that the product was not manufactured to specifications.We are inconclusive as to why this failure mode occurred.The appropriate internal personnel have been notified and we will continue to monitor for similar complaints.

Event Description

Additional information: a new picc had to be inserted.

• Brand Name: DOUBLE LUMEN PERIPHERALLY INSERTED CENTRAL VENOUS CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCUALR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; bloomington IN 47404
• Manufacturer Contact: rita harden, director ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 4336048
• MDR Text Key: 5178829
• Report Number: 1820334-2014-00637
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002086937
• UDI-Public: (01)00827002086937(17)161101(10)4653987
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/07/2014

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: 11/01/2016
• Device Catalogue Number: PICDS-701-MPIS-NT
• Device Lot Number: 4653987
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2014
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 11/06/2014
• Device Age: 1 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/11/2014
• Initial Date FDA Received: 12/09/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/01/2013
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 53 YR