MAUDE Adverse Event Report: COOK INC; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/08/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(b)(4).The event is currently under investigation.
Event or Problem Description
The device was placed in the patient and it was noted that the slide clamp was not present.The line needed to be removed and replaced.A section of the device did not remain inside the patient's body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Cook spectrum minocycline/rifampin impregnated triple lumen central venous catheter set.(b)(4).Investigation - evaluation : a review of the complaint history, drawings, documentation and manufacturing instructions of the device was conducted during the investigation.The complaint device was not returned therefore, no physical examinations could be performed; however, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.Review of 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 information provided, no product returned and the results of our investigation, we confirmed the reported event based on the provided customer description.Since the placement of the blue slide clamps is an in-process manufacturing step and was not manufactured per design specifications, the root cause would be manufacturing related.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.
Event or Problem Description
The device was placed in the patient and it was noted that the slide clamp was not present.The line needed to be removed and replaced.A section of the device did not remain inside the patient¿s body.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

• 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: 5799236
• Report Number: 1820334-2016-00607
• Device Sequence Number: 686938
• Product Code: FOZ
• UDI-Device Identifier: 00827002101944
• UDI-Public: (01)00827002101944(17)181104(10)6736697
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: K033843
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2016

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-UTLM-501J-ABRM
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 06/16/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/15/2016
• Supplement Report FDA Received Date: 11/22/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1