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	Fitting Problem (2183)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/16/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).(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
International customer reported that a cook total parenteral nutrition (tpn) double lumen catheter was implanted into a patient on (b)(6) 2016.The extension tubing of the catheter reportedly fractured on (b)(6) 2017.The conditions and circumstances surrounding the event are not known.(1820334-2017-00680) a kit was obtained to repair the device; the repair kit did not appear to be the proper size for the needed repair (1820334-2017-00771).A second repair kit was obtained and the catheter successfully repaired.The repaired catheter then fractured several hours later (1820334-2017-00772) and was subsequently explanted and replaced with a new tpn catheter on (b)(6) 2017.No further event or patient information was provided.The device is not available for evaluation.This is one of three separate reports being submitted as three events were reported.See mdr numbers 1820334-2017-00680, 1820334-2017-00771 and 1820334-2017-00772 for all associated events.The same patient is involved in all events.
Additional Manufacturer Narrative
Investigation-summary: a review of complaint history, device history record, instructions for use (ifu), specifications, and quality control data was conducted during the investigation.Cook tpn double lumen tpn catheter set (lot6878219) was not returned; therefore, device failure analysis and physical examination of the device used in this case could not be performed.A document-based investigation evaluation showed no evidence to suggest the product was not made to specifications.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.Review of the device history record did not observe any non-conformances that may have contribute to this failure mode.There were two other reported complaints associated to the complaint lot number that are related to this complaint.The two complaints were submitted under mdr numbers 1820334-2017-00680 and 1820334-2017-00772.The same patient was involved in all events.Based on the provided information, no product returned and the investigation, a definitive root cause cannot be established or reported at this time.Per the quality engineering risk assessment no further action is required.We will continue to monitor for similar events.

• 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: 6490315
• Report Number: 1820334-2017-00771
• Device Sequence Number: 1082665
• Product Code: FOZ
• UDI-Device Identifier: 00827002018808
• UDI-Public: (01)00827002018808(17)190408(10)6878219
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/30/2017

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-TPNS-7.0D-65
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/17/2017
• Supplement Date Received by Manufacturer: 11/14/2017
• Initial Report FDA Received Date: 04/13/2017
• Supplement Report FDA Received Date: 11/30/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 2 YR