MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; CATHETER, RETENTION TYPE, BALLOON

Model Number DYND11706

Device Problems Flushing Problem (1252); Detachment of Device or Device Component (2907)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

6.0 f foley inserted prior to voiding cystourethrogram (vcug) study.Catheter inserted with ease and with good urine return.Balloon filled with 3ml sterile water and catheter connected to leg bag.While in radiology, the catheter was detached from bag and attempted to flush prior to inserting contrast.Catheter would not flush or return urine.Attempted to deflate balloon to remove catheter and the tubing would collapse but no fluid would return.Finally, a stylet was attempted to pass through and would not pass.Catheter was cut, balloon self-deflated and catheter came out.

Event Description

6.0 f foley inserted prior to voiding cystourethrogram (vcug) study.Catheter inserted with ease and with good urine return.Balloon filled with 3ml sterile water and catheter connected to leg bag.While in radiology, the catheter was detached from bag and attempted to flush prior to inserting contrast.Catheter would not flush or return urine.Attempted to deflate balloon to remove catheter and the tubing would collapse but no fluid would return.Finally, a stylet was attempted to pass through and would not pass.Catheter was cut, balloon self-deflated and catheter came out.

• Brand Name: MEDLINE
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1 medline place; mundelein IL 60060
• MDR Report Key: 13577001
• MDR Text Key: 285951095
• Report Number: 13577001
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/15/2022

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
• Device Operator: Health Professional
• Device Model Number: DYND11706
• Device Catalogue Number: DYND11706
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/22/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA
• Patient Sex: Male
• Patient Weight: 6 KG
• Patient Race: White