MAUDE Adverse Event Report: COOK INC COOK PERITONEAL LAVAGE SET

Catalog Number	C-PLS-901
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/29/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 procedure the peritoneal lavage catheter was leaking on the surface of the abdomen.A crack/tear was found at the root of the catheter.It was further noted that the catheter had a hole near the hub.The catheter was replaced with another catheter.No other information was made available.

• Brand Name: COOK PERITONEAL LAVAGE SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8171793
• Report Number: 1820334-2018-03830
• Device Sequence Number: 2190332
• Product Code: GBW
• UDI-Device Identifier: 00827002052673
• UDI-Public: (01)00827002052673(17)180508(10)5870318
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/17/2018

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: 05/08/2018
• Device Catalogue Number: C-PLS-901
• Device Lot Number: 5870318
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 12/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1