MAUDE Adverse Event Report: COOK INC TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER SET

Model Number	N/A
Medical Device Problem Code	Occlusion Within Device (1423)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).No known impact or consequence to patient.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 customer reported that the tenckhoff spiral chronic peritoneal dialysis catheter would not flush with fluid.Another catheter was opened to complete the procedure, with no further product issues reported.The customer confirmed that no additional procedures were necessitated and no patient adverse events occurred due to the issue.Additional information was requested but could not be provided by the reporter.The product is reportedly unavailable for return.
Additional Manufacturer Narrative
Investigation ¿ evaluation: a review of the complaint history, device history record, documentation, instructions for use (ifu), and quality control data of the device was conducted during the investigation.The product was not returned, so physical evaluation could not be performed.However, a review of documentation was conducted.A review of the device history record found no other non-conformances associated with the complaint device lot number (7996497).Additionally, a search of the manufacturer's complaint database found one other complaint associated with the complaint device lot number (7996497).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.Based on the provided information 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.

• Brand Name: TENCKHOFF SPIRAL CHRONIC PERITONEAL DIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6976256
• Report Number: 1820334-2017-03649
• Device Sequence Number: 519096
• Product Code: GBW
• UDI-Device Identifier: 00827002092693
• UDI-Public: (01)00827002092693(17)200705(10)7996497
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/20/2018

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-TCPS-15-41-78-SPRL-14-6
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/12/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 10/25/2017
• Supplement Report FDA Received Date: 03/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1