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

Catalog Number	DYND150116
Medical Device Problem Codes	Deflation Problem (1149); Failure to Deflate (4060)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported the device was being used for chemotherapy administration.It was reported that the balloon would not deflate and the patient was sent to provider's office for a procedure to remove the catheter.It has been determined that the reported event caused or contributed to serious injury, therefore, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
Balloon would not deflate.

• Common Device Name: TRAY,FOLEY,LATX,16FR,10ML,W/SD
• 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: 19923808
• Report Number: 1417592-2024-00787
• Device Sequence Number: 18171183
• 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
• Report Date (Section B): 08/06/2024

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
• Device Catalogue Number: DYND150116
• Device Lot Number: 24BBM632
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/09/2024
• Initial Report FDA Received Date: 08/06/2024
• 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 Sex: Unknown