MAUDE Adverse Event Report: C. R. BARD, INC. BARDEX I. C. COMPLETE CARE FOLEY CATHETER; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number	903316A
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/25/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
Foley catheter inserted in urethra and into the bladder.Urine visualized in drainage tube.Staff inflated balloon for the first time through balloon port with 10ml of prepackaged sterile water.Unscrewed syringe from balloon port, and balloon port fell off of the catheter.Water leaked out from tubing where balloon port had been.Gently pulled catheter and it slipped right out of urethra.Fda safety report id# (b)(4).

• Brand Name: BARDEX I. C. COMPLETE CARE FOLEY CATHETER
• Common Device Name: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC. ; MX
• MDR Report Key: 8847829
• Report Number: MW5088581
• Device Sequence Number: 16666253
• Product Code: MJC
• UDI-Device Identifier: 00801741024504
• UDI-Public: (01)00801741024504
• Combination Product (Y/N): N
• Initial Reporter State: KS
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Voluntary
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 07/26/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 903316A
• Device Catalogue Number: 903316A
• Device Lot Number: NGDR0459
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 30 YR
• Patient Weight: 71