MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE; MAGIC3 INTERMITTENT CATHETER

Model Number	53516G
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/10/2022
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 patient was reusing the magic 3 go hydrophilic male intermittent catheter and running under water to re lubricate the catheter.It was also stated that the patient experienced bleeding while using the catheter.The representative advised that the running under water would not re lubricate the catheters, and they only meant to be one time use.It was noted that the patient had been using the product for more than 90 days.No medical intervention was reported.
Additional Manufacturer Narrative
Upon further review, it has been determined that this event is not reportable.The device was not returned.
Event or Problem Description
It was reported that the patient was reusing the magic 3 go hydrophilic male intermittent catheter and running under water to re lubricate the catheter.It was also stated that the patient experienced bleeding while using the catheter.The representative advised that the running under water would not re lubricate the catheters, and they only meant to be one time use.It was noted that the patient had been using the product for more than 90 days.No medical intervention was reported.Per follow-up via phone on 07feb2022, patient stated that no medical attention required for bleeding and they received a different catheter and no longer had any catheter issues.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER WITH SURE-GRIP¿ SLEEVE
• Common Device Name: MAGIC3 INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13392937
• Report Number: 1018233-2022-00251
• Device Sequence Number: 4779553
• Product Code: MJC
• UDI-Device Identifier: 00801741069727
• UDI-Public: (01)00801741069727
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K033477
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/22/2022
• 2 Devices were Involved in the Event: 1 2

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 Expiration Date: 12/31/2021
• Device Model Number: 53516G
• Device Catalogue Number: 53516G
• Device Lot Number: NGBP0262
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/10/2022
• Supplement Date Received by Manufacturer: 04/18/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 05/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male