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

Model Number DYND11554

Device Problem Inflation Problem (1310)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/01/2020

Event Type  malfunction  

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 Description

It was reported that the foley catheter balloon did not properly inflate, which required removal and re-insertion.

• Brand Name: Medline
• Type of Device: CATHETER,FOLEY,100% SILICONE,10FR,3ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, il ; 6434960
• MDR Report Key: 9935298
• MDR Text Key: 190198255
• Report Number: 1417592-2020-00034
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 10884389034422
• UDI-Public: 10884389034422
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND11554
• Device Catalogue Number: DYND11554
• Device Lot Number: 59219091894
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 24 MO
• Patient Weight: 16