MAUDE Adverse Event Report: COOK INC COOK TPN SINGLE LUMEN CATHETER REPAIR SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/30/2017
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
International customer reported that a customer called and stated "when the feeding catheter which was cracked on the child who was wearing it for a while the guide did not fit in the catheter." additional event information was requested; no further information was provided as of the date of this report.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the device history record, documentation, manufacturing instructions, specifications, drawing, quality control, and a visual inspection and functional evaluation of the returned device were conducted during the investigation.The visual inspection of the returned device confirmed the return of 6 cm of catheter and 7mm of wire which extended past the end of the catheter portion.An additional length of wire was also returned separated from the other pieces of the device.A functional test of the device noted no leaks under pressure.The difficulty experienced by the customer could not be recreated in the laboratory.Additionally, a document based investigation evaluation was performed.There is no evidence to suggest the product was not made to specifications.A review of the device history record showed 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, the examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: COOK TPN SINGLE LUMEN CATHETER REPAIR SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6764397
• Report Number: 1820334-2017-02192
• Device Sequence Number: 1095776
• Product Code: DQY
• UDI-Device Identifier: 00827002021204
• UDI-Public: (01)00827002021204(17)171101(10)7564466
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/07/2018

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-RHCS-3.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2017
• Supplement Date Received by Manufacturer: 01/29/2018
• Initial Report FDA Received Date: 08/03/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1