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

Catalog Number	C-TAPS-9.5-31-12-0-10.5
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The field for sections was not populated due to a technical limitation: common name: catheter, peritoneal; product code: gbw.This mdr is being filed after the associated complaint was reviewed under remediation protocol (b)(4), complaint/mdr retrospective review and remediation and reassessed as reportable.Additional complaint investigation and record remediation was not performed.
Event or Problem Description
It was reported that during the peritoneal dialysis, a luer lock connection on tenckhoff acute peritoneal dialysis catheter was leaking when connected o another manufacturer's dialysis bag.The luer lock was not a "snug fit" with the other manufacturer's kit.There were no adverse effects reported due to the event and no report of an additional procedure.

• Brand Name: TENCKHOFF ACUTE PERITONEAL DIALYSIS CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8167876
• Report Number: 1820334-2018-03821
• Device Sequence Number: 19269459
• Product Code: GBW
• UDI-Device Identifier: 00827002090859
• UDI-Public: (01)00827002090859(17)170721(10)5112104
• Combination Product (Y/N): N
• Initial Reporter Country: GB
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/16/2018

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 Expiration Date: 07/21/2017
• Device Catalogue Number: C-TAPS-9.5-31-12-0-10.5
• Device Lot Number: 5112104
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 12/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1