MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; 1LYR 14FR 10ML SILVER UM TRAY

Catalog Number	DYND160514H
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the twist valve was missing on the urine meter that came pre-connected with the foley catheter.Per report, the patient needed the foley catheter for c- section.The missing twist valve on the urine meter was reportedly not identified until after the foley catheter was already placed in patient and leaking was noticed coming from the urine meter.The entire foley catheter system (foley catheter with pre-connected urine meter) was replaced.There was no serious injury or follow-up care reported related to the event.Due to the reported foley catheter re-insertion, this medwatch is being filed.The sample was returned for evaluation and the missing twist valve on the urine meter was confirmed.A root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the twist valve on the urine meter (that was pre-connected to the foley catheter) was missing.

• Common Device Name: 1LYR 14FR 10ML SILVER UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7934968
• Report Number: 1417592-2018-00110
• Device Sequence Number: 2014615
• 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): 10/04/2018

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 Catalogue Number: DYND160514H
• 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: 09/19/2018
• Initial Report FDA Received Date: 10/04/2018
• 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: 22 YR
• Patient Weight: 127