MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE; TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG

Model Number	DYND11003
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that on (b)(6) 2021 a urinary catheter that was inserted on (b)(6) 2021 was leaking.A new urinary catheter was placed and 2-3 hours later, it was noted that the urinary catheter balloon only had 2ml of the 10ml saline that was originally injected.The urinary catheter was replaced again and no further incident was reported.Despite multiple good faith attempts, the reporting facility was unable or unwilling to provide any additional information beyond what was originally reported.No adverse patient impact was originally reported.No sample was returned for evaluation.A root cause could not be determined at this time.Due to the reported need for urinary catheter placement, 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 urinary catheter was leaking.

• Brand Name: MEDLINE
• Common Device Name: TRAY,FOLEY,CATH,SIL-ELAST,16FR,10ML,BG
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 12300494
• Report Number: 1417592-2021-00138
• Device Sequence Number: 11765965
• Product Code: OHR
• UDI-Device Identifier: 10080196991471
• UDI-Public: 10080196991471
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2021

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: DYND11003
• Device Catalogue Number: DYND11003H
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/15/2021
• Initial Report FDA Received Date: 08/10/2021
• 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