MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER TRAY

Catalog Number	DYND160514
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	08/16/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was reported on (b)(6) 2018 that a drain bag was noted with a leak and no additional information was reported related to the event.On (b)(6) 2018 the manufacturer received additional information that a foley catheter was placed in a female patient before a caesarian section procedure was performed and noted to be leaking around the urometer seal against the bag less than an hour after the device was in use.The facility does not store individual replacement tubing or drainage bags so the entire catheter system was replaced with no further incident.There was no serious injury, follow-up medical care or additional medical intervention required related to the incident, however medical intervention to replace the foley catheter was necessary.No additional information is available.The sample was returned for evaluation and the reported issue of leaking at the urine meter was verified through the presence of twist valves broken off on the received sample.Based on visual inspection of the received sample, the suspected root cause is a blunt force to the twist valve (i.E., hit on wall, drop), leading to the twist valve inner stem cracking off.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported that an indwelling catheter drainage bag at the urometer connection point was noted to be leaking around the uroseal against the bag.

• Common Device Name: CATHETER TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7938955
• Report Number: 1417592-2018-00112
• Device Sequence Number: 1859350
• Product Code: OHR
• UDI-Device Identifier: 10884389287729
• UDI-Public: 10884389287729
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 10/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: DYND160514
• Device Lot Number: 18PB4197
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/11/2018
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/25/2018
• Initial Report FDA Received Date: 10/05/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 31 YR
• Patient Weight: 119