MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. Medline; CATHETER,FOLEY,100% SILICONE,10FR,3ML,LF

Model Number	DYND11554
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported a foley catheter had to be replaced due to the balloon not properly inflating.According to the nurse, the catheter kept falling out so it was removed, which was reported to be very uncomfortable for the patient.That same day a new catheter was placed and without further issues.No sample was returned for evaluation.No additional information was available.Due to the reported catheter re-insertion and in an abundance of caution this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the foley catheter balloon did not properly inflate, which required removal and re-insertion.

• Brand Name: Medline
• Common Device Name: CATHETER,FOLEY,100% SILICONE,10FR,3ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 9935298
• Report Number: 1417592-2020-00034
• Device Sequence Number: 2808733
• Product Code: EZL
• UDI-Device Identifier: 10884389034422
• UDI-Public: 10884389034422
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/07/2020

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: DYND11554
• Device Catalogue Number: DYND11554
• Device Lot Number: 59219091894
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/13/2020
• Initial Report FDA Received Date: 04/08/2020
• 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: 24 MO
• Patient Weight: 16