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

Model Number	53618
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/14/2022
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.
Event or Problem Description
It was reported that these magic 3 go hydrophilic male intermittent catheters were not lubricated and caused bleeding.No medical intervention was reported.Per follow up via phone on (b)(6) 2022, it was stated that the issue had been resolved and the bleeding resolved on its own.
Additional Manufacturer Narrative
The reported issue was inconclusive as no sample was returned for evaluation.A potential root cause for this failure could be "operator error".The lot number was unknown; therefore, the device history record could not be reviewed.A labeling review was not performed because labelling could not have prevented the reported failure.The device was not returned.
Event or Problem Description
It was reported that these magic 3 go hydrophilic male intermittent catheters were not lubricated and caused bleeding.No medical intervention was reported.Per follow up via phone on 22dec2022, it was stated that the issue had been resolved and the bleeding resolved on its own.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 16068376
• Report Number: 1018233-2022-09980
• Device Sequence Number: 17711009
• Product Code: KOD
• UDI-Device Identifier: 00801741068591
• UDI-Public: (01)00801741068591
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• 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): 01/12/2023

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: 53618
• Device Catalogue Number: 53618
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/14/2022
• Supplement Date Received by Manufacturer: 01/12/2023
• Initial Report FDA Received Date: 12/29/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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