MAUDE Adverse Event Report: COOK INC COOK SPECTRUM; 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 Known Impact Or Consequence To Patient (2692)
Date of Event	08/10/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.(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 there was a crack in the hub, which resulted in a continual leak from the port.The crack was taped and wrapped.Because the patient was reportedly difficult to catheterize, the customer left the device in and provided care.The account confirmed that no patient adverse events were reported as a result of this incident.
Additional Manufacturer Narrative
Additional information: brand name: cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter tray.Investigation - evaluation : a review of dimensional verification, complaint history, device history record, drawings, instructions for us (ifu), 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 1.1cm long from the proximal end.A leak test showed leakage coming from the crack.No damage noted on the other hubs.The blue hub extension measured within specification.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.Review of the device history record shows 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: COOK SPECTRUM
• 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: 6848731
• Report Number: 1820334-2017-02794
• Device Sequence Number: 99369
• Product Code: FOZ
• UDI-Device Identifier: 00827002241374
• UDI-Public: (01)00827002241374(17)191201(10)7970118
• Combination Product (Y/N): N
• Initial Reporter State: MA
• 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 Health Care Professional
• 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?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-UTLMY-701J-ABRM-CUSTOM-0019
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 08/16/2017
• Supplement Date Received by Manufacturer: 12/01/2017
• Initial Report FDA Received Date: 09/07/2017
• 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
• Patient Age: 56 YR