MAUDE Adverse Event Report: BARD MEDICAL BARD; 16 FR, LATEX-FREE FOLEY CATHETER

Model Number 897516

Device Problems Folded (2630); Mechanical Jam (2983); No Flow (2991)

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

Event Date 01/15/2017

Event Type  Injury  

Event Description

During sterile, indwelling catheter insertion, no urine drainage was obtained.When catheter was withdrawn, foley tubing had folded, and tip was visible next to tubing.Physician at the bedside with rn had to utilize several maneuvers to remove catheter because it was stuck in the urethra.

• Brand Name: BARD
• Type of Device: 16 FR, LATEX-FREE FOLEY CATHETER
• Manufacturer (Section D): BARD MEDICAL; covington GA 30014
• MDR Report Key: 6266315
• MDR Text Key: 65503906
• Report Number: MW5067331
• Device Sequence Number: 1
• Product Code: EZL
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/17/2017

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: Health Professional
• Device Model Number: 897516
• Device Lot Number: NGAV4939
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/17/2017
• 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: 36 YR