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

Catalog Number	DYND150116
Medical Device Problem Code	Obstruction of Flow (2423)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/24/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
According to the customer, on 01/24/2024 after the foley catheter was utilized for administration of "chemotherapy medications into the bladder" the "fluid in the balloon would not come out when a syringe was attached per standard practice" for the removal of the foley catheter.
Additional Manufacturer Narrative
According to the customer, on 01/24/2024 after the foley catheter was utilized for administration of "chemotherapy medications into the bladder" the "fluid in the balloon would not come out when a syringe was attached per standard practice" for the removal of the foley catheter.The customer reported they used "multiple syringes", had the patient "move positions", and cut the "side arm" but they continued to be unsuccessful with removing the water for ballon deflation.The customer reported the patient was seen by a physician who attempted to manipulate the catheter but was also unsuccessful in removing the catheter.The customer reported an "ultrasound" was taken to confirm the balloon was in the bladder.The customer reported they attempted to insert a "guidewire in the side port without success" due to the guidewire hitting "resistance".The customer reported the "blockage appears to be right at the y where the instillation port enters into the main catheter".The customer reported they "cut the catheter with scissors" after the multiple failed attempts to deflate the balloon and the balloon deflated.The customer reported when the balloon deflated it drained the bladder of active chemotherapy and the patient received "less than a therapeutic amount of time with the chemotherapy in his bladder".The patient reported the product was not saved due to "contamination with chemotherapy".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.
Additional Manufacturer Narrative
Update to 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 drive; northfield, IL 60093
• MDR Report Key: 18759031
• Report Number: 1417592-2024-00090
• Device Sequence Number: 17719275
• Product Code: OHR
• UDI-Device Identifier: 40195327043330
• UDI-Public: 40195327043330
• 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,Followup
• Report Date (Section B): 05/07/2024

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: DYND150116
• Device Lot Number: 2167500QX , 23HBG768
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/25/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 05/07/2024
• 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