MAUDE Adverse Event Report: BARD MEDICAL DIVISION FOLEY CATHETER; INDWELLING FOLEY CATHETER

Lot Number NGAR0720

Device Problem Device Slipped (1584)

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

Event Date 09/12/2016

Event Type  Injury  

Event Description

Two bard indwelling 16f silicone foley catheters fell out of the pt with balloon deflated on 2 separate events.Both times the balloon were tested by the nurse prior to insertion without difficulties.The 2 foley caths were placed by 2 different nurses.

• Brand Name: FOLEY CATHETER
• Type of Device: INDWELLING FOLEY CATHETER
• Manufacturer (Section D): BARD MEDICAL DIVISION; covington GA 30014
• MDR Report Key: 5979781
• MDR Text Key: 55815749
• Report Number: MW5065034
• Device Sequence Number: 2
• 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: 09/23/2016
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: NGAR0720
• Is the Reporter a Health Professional?: Yes
• 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: 67 YR
• Patient Weight: 71