MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,FOLEY 100% SILI 18FR 10ML

Catalog Number DYND11528H

Device Problems Burst Container or Vessel (1074); Material Integrity Problem (2978)

Patient Problem Insufficient Information (4580)

Event Date 11/06/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported by the customer that during the week of (b)(6) 2023, "foley balloon failed".It was reported that this occurred while in the patient.A sample was requested to be returned for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

Foley catheter balloon failure.

• Type of Device: TRAY,FOLEY 100% SILI 18FR 10ML
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: kelly zampella ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18237088
• MDR Text Key: 329367151
• Report Number: 1417592-2023-00474
• Device Sequence Number: 1
• Product Code: OHR
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Catalogue Number: DYND11528H
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/06/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other