MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; CATHETER, INTRAVASCULAR, DIAGNOSTIC

Lot Number 21ABN465; 20IBD471; 20IBG585

Device Problems Deflation Problem (1149); Material Puncture/Hole (1504)

Patient Problem Insufficient Information (4580)

Event Date 02/22/2021

Event Type  malfunction  

Event Description

Indwelling urethral catheter placed in patient per orders.2 hours later, foley noted to be out of patient with balloon partially inflated.Foley balloon noted to have a hole in it upon further examination.3 lot numbers for foley catheters on unit: 21abn465, 20ibd471, 20ibg585.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: CATHETER, INTRAVASCULAR, DIAGNOSTIC
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11619197
• MDR Text Key: 243939293
• Report Number: 11619197
• Device Sequence Number: 1
• Product Code: DQO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 03/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Lot Number: 21ABN465; 20IBD471; 20IBG585
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/31/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 12045 DA
• Patient Weight: 76