MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,100% SILICONE,18FR,10ML,LF

Model Number DYND11520

Device Problem Inflation Problem (1310)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/01/2021

Event Type  malfunction  

Manufacturer Narrative

It was reported that the urinary catheter balloon would not inflate and the urinary catheter would not remain inserted.Despite multiple good faith attempts the original reporter was unable or unwilling to provide any additional information to the manufacturer.No adverse patient impact was originally reported to the manufacturer.No sample has been returned to the manufacturer for evaluation.A root cause for the reported incident was unable to be determined.Due to the reported incident, 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 urinary catheter balloon would not inflate.

• Brand Name: MEDLINE
• Type of Device: TRAY,FOLEY,100% SILICONE,18FR,10ML,LF
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753 ; 2249311458
• MDR Report Key: 11537099
• MDR Text Key: 246058849
• Report Number: 1417592-2021-00040
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 10080196997060
• UDI-Public: 10080196997060
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYND11520
• Device Catalogue Number: DYND11520
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other