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

Catalog Number DYND160814

Device Problem Crack (1135)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/24/2018

Event Type  malfunction  

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 Description

It was reported that a urine meter crack was identified and that the patient's urinary catheter was replaced.

• Type of Device: 1LYR 14FR 10ML 100%SILI UM TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 8365920
• MDR Text Key: 139076546
• Report Number: 1417592-2019-00028
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10884389287408
• UDI-Public: 10884389287408
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND160814
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR
• Patient Weight: 78