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

Model Number	51912
Medical Device Problem Code	Material Discolored (1170)
Health Effect - Clinical Code	Urinary Tract Infection (2120)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem Description
It was reported that there was a brown coating on the magic 3 catheter.The patient reportedly developed a urinary tract infection after using the catheter and was prescribed antibiotics.
Additional Manufacturer Narrative
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: ¿use of certain antimicrobial agents may allow overgrowth of non-susceptible organisms including yeast and fungi.If this occurs, or if irritation, sensitization or superinfection develops, discontinue use and institute appropriate therapy.Pediatric use: safety and effectiveness in children has not been established.Pregnancy: pregnancy category c: nitrofurazone has been shown to have an embryocidal effect in rabbits when given in oral doses thirty times the human dose.There are no adequate and well".
Event or Problem Description
It was reported that there was a brown coating on the magic 3 catheter.The patient reportedly developed an urinary tract infection after using the catheter and was prescribed antibiotics.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC 3 CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8860902
• Report Number: 1018233-2019-04450
• Device Sequence Number: 514470
• Product Code: MJC
• UDI-Device Identifier: 00801741068287
• UDI-Public: (01)00801741068287
• 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): 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 51912
• Device Catalogue Number: 51912
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 08/21/2019
• 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