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

Model Number	N/A
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	08/22/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 or Problem Description
It was reported by the customer that, 8 days after implantation of the triple lumen polyurethane central venous catheter, it had to be removed and replaced because it was discovered that the blue lumen was cracked.The patient required an additional procedure to replace the central line.
Additional Manufacturer Narrative
A review of dimensional verification, functional testing, complaint history, device history record, drawing, trends, and quality control data was conducted during the investigation.Visual inspection and functional testing of the returned device were performed.The device was returned in used condition.The blue hub had a crack 1.2 cm long from the proximal end.There were no cracks or damage on the red or white hub.The leak test showed leakage originating from the crack.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record showed no nonconforming events which could contribute to this failure mode.It should be noted there were no other reported complaints for this lot number.Based on the provided information, inspection of returned product, and the investigation results, a definitive root cause cannot be determined at this time; however, measures have been initiated to address this failure mode.The appropriate personnel have been notified and monitoring will continue to be performed for similar complaints.

• Brand Name: TRIPLE LUMEN POLYURETHANE CENTRAL VENOUS CATHETER TRAY
• Common Device Name: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6834732
• Report Number: 1820334-2017-02787
• Device Sequence Number: 16541517
• Product Code: FOZ
• UDI-Device Identifier: 00827002232594
• UDI-Public: (01)00827002232594(17)190930(10)7802338
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K081113
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-701J-CCT-A-RD
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/15/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 08/31/2017
• Supplement Report FDA Received Date: 12/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATIONS INFUSED THROUGH CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 16 YR