MAUDE Adverse Event Report: C. R. BARD, INC. BARD ALL SILICONE TEMPERATURE SENSING URINE METER FOLEY TRAY; CATHETER, RETENTION TYPE, BALLOON

Model Number 909418

Device Problem Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/13/2017

Event Type  malfunction  

Event Description

Four foley catheters were noted to have issues.The foley catheters were in place (4 had holes identified in 1 shift) holes noted somewhere on collection bag.Noted by pct when emptying the bag and leakage was noted.It is supposed to be a closed system and each of the bags had an open area with risk for catheter associated urinary tract infection (cauti).

• Brand Name: BARD ALL SILICONE TEMPERATURE SENSING URINE METER FOLEY TRAY
• Type of Device: CATHETER, RETENTION TYPE, BALLOON
• Manufacturer (Section D): C. R. BARD, INC.; 1211 mary magnan blvd.; madison GA 30650
• MDR Report Key: 6471778
• MDR Text Key: 72108636
• Report Number: 6471778
• 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: Other
• Type of Report: Initial
• Report Date: 03/17/2017

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: No Information
• Device Model Number: 909418
• Device Catalogue Number: 909418
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/17/2017
• Event Location: Hospital
• Date Report to Manufacturer: 03/17/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1