MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; TTL1LYR 16FR10ML 100%SILI DB TRA

Catalog Number URO170716

Device Problem Deflation Problem (1149)

Patient Problem No Code Available (3191)

Event Date 11/17/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during an unidentified procedure, the physician ordered for the inserted urinary catheter to be deflated and advanced further into the patient.Reportedly, the urinary catheter balloon was unable to be deflated.According to the reporting facility, only 5ml of fluid was able to removed from the 10ml balloon.When the issue was identified, the "urinary catheter tubing" was reportedly cut to allow for balloon deflation.It was reported that the urinary catheter balloon was unable to be fully deflated, that the urinary catheter was removed from the patient with the "balloon partially intact," and that the patient experienced bleeding to the insertion site during the removal process.A new urinary catheter was inserted and no further incident was reported to the manufacturer.A sample was returned to the manufacturer for evaluation.Visual inspection of the returned sample revealed that the inflation valve had been partially severed as described by the reporting facility.No other defects nor abnormalities were visually noted.Functional evaluation of the returned sample was performed with no occlusions noted in either the inflation lumen or the inflation valve.Examination of the inflation lumen and the inflation valve showed no characteristics that would contributed towards the reported product problem/issue.A definitive root cause for the reported product problem/issue was unable to determined, however, it is possible that an unknown patient-specific condition may have impeded the deflation ability of the urinary catheter balloon.Due to the need for medical intervention during the reported incident, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

It was reported that the urinary catheter balloon was unable to be deflated.

• Type of Device: TTL1LYR 16FR10ML 100%SILI DB TRA
• 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: 9432454
• MDR Text Key: 190761803
• Report Number: 1417592-2019-00210
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10888277866911
• UDI-Public: 10888277866911
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: URO170716
• Device Lot Number: 592180505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2019
• Date Manufacturer Received: 11/20/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 76 YR
• Patient Weight: 82