MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER; MAGIC 3 ANTIBACTERIAL INTERMITTENT CATHETER

Model Number	53916
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The device was not returned.
Event or Problem Description
It was reported that the magic 3 intermittent catheter was difficult to insert into the bladder due to blood clots that formed in the bladder as a result of radiation treatments.The patient exchanged the product for a product better suited to his condition.No medical intervention was reported.
Event or Problem Description
It was reported that the magic 3 intermittent catheter was difficult to insert into the bladder due to blood clots that formed in the bladder as a result of radiation treatments.The patient exchanged the product for a product better suited to his condition.No medical intervention was reported.
Additional Manufacturer Narrative
This report is being submitted past the regulatory timeframe.Please see attached letter for additional information.The device was not returned for evaluation.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿the catheter is intended for urinary bladder drainage in adult males and females requiring catheterization for management of incontinence, voiding dysfunction, and surgical procedures.Efficacy of the catheter in preventing urinary tract infection during intermittent use has not been established.The device is not intended to be used as a treatment for active urinary tract infection.Please contact your physician to determine which product options are best for you, paying close attention to product warnings/ precautions and adverse reactions.Active ingredient the catheter has a surface concentration of 10.2 +/- 2.0 micrograms nitrofurazone (5-nitro-2-furaldehyde semicarbazone) per mm2 of total catheter shaft area.".

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 ANTIBACTERIAL INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8501101
• Report Number: 1018233-2019-01823
• Device Sequence Number: 18887617
• Product Code: MJC
• UDI-Device Identifier: 00801741068706
• UDI-Public: (01)00801741068706
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K001143
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2019

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: Lay User/Patient
• Device Model Number: 53916
• Device Catalogue Number: 53916
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/23/2019
• Supplement Date Received by Manufacturer: 04/16/2019
• Initial Report FDA Received Date: 04/10/2019
• Supplement Report FDA Received Date: 05/30/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1