MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; CATHETER,FOLEY,100% SIL,COUDE,14FR 10ML

Catalog Number	DYND11591
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that the urinary catheter balloon burst while inserted in a patient.It is unknown how long the urinary catheter was inserted for prior to the reported incident.When the burst balloon was identified, the urinary catheter was removed and replaced with a new urinary catheter.According to the reporting facility, there was no impact or adverse effect to the patient or to the patient's stability.The urinary catheter involved in the reported incident was returned to the manufacturer for evaluation.Visual inspection was performed and a clean tear and a scratch were identified in the balloon material.The balloon was inflated with 10ml of water and leaking was noted from the balloon.Although it is possible that an external force punctured the balloon material while in use, leading to the tear propagating, a definitive root cause for the reported incident could not be determined.Due to the need for medical intervention to insert a new urinary catheter, 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 the urinary catheter balloon burst while inserted in a patient.

• Common Device Name: CATHETER,FOLEY,100% SIL,COUDE,14FR 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 8348453
• Report Number: 1417592-2019-00018
• Device Sequence Number: 14004078
• Product Code: EZL
• UDI-Device Identifier: 10884389124000
• UDI-Public: 10884389124000
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 02/18/2019

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: DYND11591
• Device Lot Number: 16LE50-REF17060
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/13/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/31/2019
• Initial Report FDA Received Date: 02/18/2019
• 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 Weight: 68