MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; 1LYR 14FR 10ML 100%SILI UM TRAY

Catalog Number	DYND160814
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/24/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that a urine meter crack was identified and it began to leak.No additional sources of leakage were identified by the reporting facility.Reportedly, when the urine meter crack was identified, the urinary catheter was removed and replaced.According to the reporting facility, there was no impact or adverse effect to the patient or the patient's stability.The sample involved in the reported incident was returned to the manufacturer for evaluation.Visual inspection was performed and the inlet tubing connection was found to have fully cracked off from the rest of the urine meter with hairline fractures progressing outward from where the connection had broken off.The reported product issue was confirmed and the suspected root cause is a blunt force to the tubing connection (i.E.Drop, hit by bed, etc.) that led to the inlet tubing connection cracking and subsequently breaking off.Due to the need for medical intervention to replace the urinary catheter, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a urine meter crack was identified and that the patient's urinary catheter was replaced.

• Common Device Name: 1LYR 14FR 10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8365920
• Report Number: 1417592-2019-00028
• Device Sequence Number: 16865630
• Product Code: OHR
• UDI-Device Identifier: 10884389287408
• UDI-Public: 10884389287408
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 02/25/2019

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: DYND160814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2019
• Initial Report FDA Received Date: 02/25/2019
• 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
• Patient Age: 72 YR
• Patient Weight: 78