MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TRAY TTL VENT 100%SILI UM 16FR

Catalog Number	URO180816S
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was initially reported that the foley catheter was found disconnected with the drainage bag tubing, with the yellow tamper seal still intact.It was added that the patient's foley catheter had to be replaced.Despite good faith efforts to obtain additional information, no further patient, product, procedural or event details are available.Due to the reported incident and the required foley catheter exchange, this medwatch is being filed.The sample has been returned for evaluation.The reported issue of the catheter disconnecting from the drainage bag tubing was confirmed through visual inspection of the received sample.The suspected root cause is an assembly error in the kit packing process having not inserted the tubing adapter adequately into the funnel.Changes to the assembly instructions were implemented to address concerns of catheters disconnecting from drainage bag tubing at the yellow tamper seal.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a foley catheter exchange was required after foley catheter was found disconnected with the drainage bag tubing, with the tamper seal still intact.

• Common Device Name: TRAY TTL VENT 100%SILI UM 16FR
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 9412573
• Report Number: 1417592-2019-00218
• Device Sequence Number: 2416498
• Product Code: OHR
• UDI-Device Identifier: 10889942767038
• UDI-Public: 10889942767038
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/04/2019

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: URO180816S
• Device Lot Number: 96919020001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/26/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/18/2019
• Initial Report FDA Received Date: 12/04/2019
• 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