MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,100% SILICONE,16FR,10ML,LF

Model Number	DYND11519
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, "a catheter had fallen out." a new catheter was placed the following afternoon." email received by (b)(6), medical supply specialist, (b)(6), who provided additional information in regards to this incident.Reporter states, catheter was initially placed (b)(6) 2021, for urinary retention.Reporter states, upon insertion there nothing unique about the patient or the case at hand that could have motivated this incident.The full 10mls of water in the water syringe from the kit was used to inflate that balloon.Reporter states, "the catheter lasted about seven hours before falling out." a new catheter was re-inserted.Reporter states, "at this time there is no issues." due to the reported incident, medical intervention and in an abundance of caution, a med watch is being filed.A sample was return and evaluated.Investigation conclusion: "the reported issue of a deflated foley catheter balloon was confirmed through functional evaluation of the sample.The catheter was evaluated by inflating the retention balloon, during inflation the retention balloon ruptured.Based on the condition of the product, the suspected root cause could be, but is not limited to, an error in the manufacturing process or a patient specific condition." if any further relevant information is identified or obtained, a supplemental med watch will be submitted.
Event or Problem Description
It was reported, "a catheter had fallen out." a new catheter was placed the following afternoon.".

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,100% SILICONE,16FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12591297
• Report Number: 1417592-2021-00181
• Device Sequence Number: 14365270
• Product Code: OHR
• UDI-Device Identifier: 10080196809790
• UDI-Public: 10080196809790
• 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: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYND11519
• Device Catalogue Number: DYND11519
• Device Lot Number: 96921050001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Initial Report FDA Received Date: 10/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 76 YR
• Patient Weight: 59