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 Code	Crack (1135)
Health Effect - Clinical Code	No Code Available (3191)
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
The customer reported that, following the placement of a double lumen polyurethane central venous catheter during a central line placement procedure, it was discovered that the white hub was cracked.The catheter was removed, and a new one was placed.The device is available for evaluation.
Additional Manufacturer Narrative
Investigation - evaluation: a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), quality control, and visual inspection and functional testing of the returned device was conducted during the investigation.The device was returned in used condition.The white hub had a 1.3cm long crack from the proximal end.The leak test showed leakage originating from the split.The white hub extension was measured and is within specification.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.Review of the device history record of the finished product as well as the component lots and subassembly lots shows no nonconforming events that would contribute to this failure mode.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: 6834506
• Report Number: 1820334-2017-02788
• Device Sequence Number: 1589404
• Product Code: FOZ
• UDI-Device Identifier: 00827002232594
• UDI-Public: (01)00827002232594(17)190501(10)7583719
• 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
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/11/2017

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: 12/11/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention