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

Model Number	N/A
Medical Device Problem Code	Device Operates Differently Than Expected (2913)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/11/2017
Type of Reportable Event	Malfunction
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 international customer reported that the clamp on the cook tpn double lumen tpn catheter was open, and when the operator attempted to close the clamp, it would spontaneously reopen and not stay closed.The clamp had to be "over-flexed" in order to keep it closed.The patient was reportedly unaffected, and the product is not available for return.
Additional Manufacturer Narrative
A review of complaint history, documentation, device history record, and quality control data was conducted during the investigation.The complaint device was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.Based on the investigation evaluation, there is no indication that a design or process related failure mode contributed to this event.Current controls for manufacturing are in place to assure functionality and device integrity prior to shipping.Review of production and quality documentation did not observe any specific issues with current manufacturing or quality controls that may have contributed to this incident.A thorough review of the device history record observed no non-conformance(s) that may have contributed to this incident associated with the complaint lot number; 7834424.Additionally, a search of the manufacturer's complaint database for similar complaints revealed this record to be the only record associated with the complaint lot number; 7834424.Based on the provided information, no product returned and the investigation, a definitive root cause cannot be established or reported at this time.The likely root cause is deemed to be; ¿inconclusive¿.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK TPN DOUBLE LUMEN TPN CATHETER SET
• 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: 6893684
• Report Number: 1820334-2017-03221
• Device Sequence Number: 711374
• Product Code: FOZ
• UDI-Device Identifier: 00827002018808
• UDI-Public: (01)00827002018808(17)200415(10)7834424
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K950118
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Dental Assistant
• Type of Report: Initial,Followup
• Report Date (Section B): 03/05/2018

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-TPNS-7.0D-65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/11/2017
• Supplement Date Received by Manufacturer: 02/07/2018
• Initial Report FDA Received Date: 09/26/2017
• Supplement Report FDA Received Date: 03/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1