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 Code Available (3191)
Date of Event	04/20/2017
Type of Reportable Event	Serious Injury
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 the lumen of a cook tpn single lumen catheter repair set cracked at an unspecified time following initial implant.The handling conditions and circumstances surrounding the event are not known.The device was explanted and replaced.The device is reportedly available for evaluation, however it had not been received by the manufacturer as of the date of this event.
Additional Manufacturer Narrative
Corrected information: product code.Investigation - evaluation.A review of the complaint history, device history record, instructions for use (ifu), specifications and visual inspection of the actual device was completed during this investigation.One catheter was returned for analysis; a visual examination noted the outer catheter is severed at the base of the taper exposing the inner catheter.The inner catheter is connected.A 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 review of the dhr indicated there to be two non-conformances associated with the complaint device lot number.Additionally; a review of complaint history found no other complaints associated with the complaint device lot number.Based on the information provided, examination of the returned product, and the results of our investigation; a definitive root cause could not be determined.Measures have been previously initiated to address this issue.Appropriate personnel have been notified and we will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• 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: 6617363
• Report Number: 1820334-2017-01403
• Device Sequence Number: 13853006
• Product Code: DQY
• UDI-Device Identifier: 00827002018686
• UDI-Public: (01)00827002018686(17)180509(10)7599804
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2017

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?: No
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: C-RHCS-4.0
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2017
• Supplement Date Received by Manufacturer: 08/29/2017
• Initial Report FDA Received Date: 06/07/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1