MAUDE Adverse Event Report: COOK INC COOK DRAINAGE POUCH SET

Model Number N/A

Device Problems Leak/Splash (1354); Material Deformation (2976)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Common device name) fcn; bag, bile collecting;urinary drainage collection kit, for indwelling catheter.(b)(4).The event is currently under investigation.

Event Description

Due to the patient's body temperature, the material of the pouch becomes very weak.The valve that prevents backflow of urine doubles inside and blocks the passage.The patient has used this device from the start of (b)(6).

Manufacturer Narrative

Investigation - evaluation a review of the complaint history, device history record, instructions for use (ifu), manufacturing instructions, quality control and visual inspection of the returned device was conducted during the investigation.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.The device was returned for evaluation.A visual inspection of the returned devices did not reveal any nonconformance for this device.Based on the information provided, and the results of our investigation, a definitive root cause could not be determined.We will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.

• Brand Name: COOK DRAINAGE POUCH SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: rita harden ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 5708956
• MDR Text Key: 48112684
• Report Number: 1820334-2016-00389
• Device Sequence Number: 1
• Product Code: EXB
• UDI-Device Identifier: 00827002146549
• UDI-Public: (01)00827002146549(17)190119(10)6534756
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 515004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Device Age: 4 MO
• Event Location: Home
• Date Manufacturer Received: 02/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/19/2016
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other