MAUDE Adverse Event Report: C. R. BARD, INC. 16" MALE CATHETER MAGIC 3 ; CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES

Model Number MAGIC

Device Problems Defective Component (2292); No Flow (2991)

Patient Problem Complaint, Ill-Defined (2331)

Event Date 07/07/2019

Event Type  malfunction  

Event Description

Using a bard magic 3 16" catheter and following the instructions, furnished by bard i inserted the catheter "until urine flows" but never got any flow after insertion to depth that may have damaged my bladder.Upon removing the catheter, i discovered a mfg defect resulting in an absence of holes in the end of the product.I contacted bard on 07/07 and spoke with (b)(4) in customer service, she referred me to the oc dept.No answer so i left a message and contact info.It has been two weeks since i left the message and have yet to hear from them.I assure they will not be contacting me so i'm informing you of this since there may be other defective ones.

• Brand Name: 16" MALE CATHETER MAGIC 3
• Type of Device: CATHETER, UROLOGICAL (ANTIMICROBIAL) AND ACCESSORIES
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 8879262
• MDR Text Key: 154314486
• Report Number: MW5088909
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 07/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 10/28/2023
• Device Model Number: MAGIC
• Device Catalogue Number: 53616G
• Device Lot Number: JUCY0271
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 71 YR
• Patient Weight: 79