MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF

Catalog Number	DYND11533
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	12/09/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the facility, the l&d department had a medline balloon cath malfunction inside a patient.The facility stated the patient said she heard a pop and thought her water broke.
Additional Manufacturer Narrative
According to the facility, the l&d department had a medline balloon cath malfunction inside a patient.The facility stated the patient said she heard a pop and thought her water broke.Foley bulb found to have ruptured inside the patient.The vagina/cervix was inspected with a sterile speculum and no remanence of the fb located; however, there was also nothing left on the catheter.The patient was to be inspected thoroughly after delivery to ensure no pieces left in uterine cavity.The facility believed the foley was not replaced and that there was no serious injury.A sample is available 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.

• Common Device Name: CATHETER,FOLEY,100%SILICONE,18FR,30ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 21080141
• Report Number: 1417592-2025-00008
• Device Sequence Number: 8386663
• Product Code: EZL
• UDI-Device Identifier: 40884389034553
• UDI-Public: 40884389034553
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/06/2025

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
• Device Catalogue Number: DYND11533
• Device Lot Number: 59224051371
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/18/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Initial Report FDA Received Date: 01/06/2025
• 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