MAUDE Adverse Event Report: MEDLINE INDUSTRIES SELECT SILICONE INDWELLING CATHETER TRAY

Catalog Number URO0180714

Device Problem Material Separation (1562)

Patient Problem Foreign Body In Patient (2687)

Event Date 06/20/2020

Event Type  Injury  

Event Description

Indwelling catheter was pulled by pt, the catheter broke off below the neck of the balloon, leaving a retained portion of the product in the bladder requiring cystoscopy surgical procedure to remove.

• Brand Name: SELECT SILICONE INDWELLING CATHETER TRAY
• Type of Device: SILICONE INDWELLING CATHETER
• Manufacturer (Section D): MEDLINE INDUSTRIES; northfield IL
• MDR Report Key: 10246261
• MDR Text Key: 198689829
• Report Number: 10246261
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Catalogue Number: URO0180714
• Device Lot Number: 19EBW812
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/25/2020
• Distributor Facility Aware Date: 06/20/2020
• Event Location: Hospital
• Date Report to Manufacturer: 06/26/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 88 YR
• Patient Weight: 69