MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; TRAY,FOLEY,LATX,16FR,10ML,W/SD

Catalog Number	DYND150116
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Urinary Incontinence (4572)
Date of Event	01/26/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, post "bladder repair" the foley was "leaking", the nurse flushed the catheter, and later it was noted that the foley balloon was "not inflated" due to the balloon being "ruptured".
Additional Manufacturer Narrative
According to the customer, post "bladder repair" the foley was "leaking", the nurse flushed the catheter, and later it was noted that the foley balloon was "not inflated" due to the balloon being "ruptured".No additional details are available related to the customer reported issue.Despite multiple good faith efforts to obtain additional information, the customer contact was unable or unwilling to provide further incident details to the manufacturer.No additional information is available.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.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.
Additional Manufacturer Narrative
Update h6: investigation conclusions.

• Common Device Name: TRAY,FOLEY,LATX,16FR,10ML,W/SD
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes dr; northfield, IL 60093-2753
• MDR Report Key: 19041951
• Report Number: 1417592-2024-00397
• Device Sequence Number: 8565249
• Product Code: OHR
• UDI-Device Identifier: 40195327043330
• UDI-Public: 40195327043330
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Catalogue Number: DYND150116
• Device Lot Number: 21722010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/07/2024
• Supplement Date Received by Manufacturer: 04/25/2024
• Initial Report FDA Received Date: 04/04/2024
• Supplement Report FDA Received Date: 05/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown