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

Catalog Number	DYND150716
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the customer, the "balloon rupture during a gemzar, cisplatin bladder instillation at the infusion clinic" when "30 ml" of the "50 ml" were administered.The customer reported they heard a "popping sound" during the administration and the patient reported there was a "sudden pressure that quickly resolved at the time of the noise".The customer reported there was "no leaking" after the incident occurred therefore, they left the foley inside the patient for the "1.5 hr dwell time".The customer reported after the dwell time, the catheter was removed and it was noted that the balloon was already deflated with a "small slit at the base".The customer reported another catheter was required to be inserted to complete another medication administration.The customer reported there was no serious injury related to the reported event.No additional information is available at this time.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.
Event or Problem Description
According to the customer, the "balloon rupture during a gemzar, cisplatin bladder instillation at the infusion clinic" when "30 ml" of the "50 ml" were administered.

• Common Device Name: TRAY,FOLEY,SIL,16FR,10ML,W/SD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 20632102
• Report Number: 1417592-2024-00951
• Device Sequence Number: 7929758
• Product Code: OHR
• UDI-Device Identifier: 40195327035120
• UDI-Public: 40195327035120
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 11/07/2024

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: DYND150716
• Device Lot Number: 24CBT120
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2024
• Initial Report FDA Received Date: 11/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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 Age: 71 YR
• Patient Sex: Male
• Patient Weight: 105 KG