MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; TRAY,FOLEY,SIL,14FR,10ML,W/SD

Catalog Number DYND150714H

Device Problem Material Rupture (1546)

Patient Problem Swelling/ Edema (4577)

Event Date 11/21/2023

Event Type  Injury  

Manufacturer Narrative

According to the customer, catheter was inserted on (b)(6) 2023 and working as expected until the balloon deflated and the catheter "came out" on (b)(6) 2023.The customer reported the balloon was inspected and had a visible "slit".The customer reported the patient had "vaginal swelling".The customer reported an additional foley catheter was placed and an "ice pad" was applied to the vaginal area.The customer did not report any serious injury.No additional information is available at this time.It has been determined that the reported event could cause or contribute to serious injury if it were to occur again.In an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

According to the customer, catheter was inserted on (b)(6) 2023 and working as expected until the balloon deflated and the catheter "came out" on (b)(6) 2023.

Manufacturer Narrative

Update to h6 investigation conclusions.

• Type of Device: TRAY,FOLEY,SIL,14FR,10ML,W/SD
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 18357339
• MDR Text Key: 330896136
• Report Number: 1417592-2023-00506
• Device Sequence Number: 1
• Product Code: OHR
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYND150714H
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/02/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other