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

Model Number	53618
Medical Device Problem Code	Device Damaged Prior to Use (2284)
Health Effect - Clinical Codes	Irritation (1941); Patient Problem/Medical Problem (2688)
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 the eyelets on the magic 3 intermittent catheter, male were not smooth and allegedly caused the patient irritation.The patient was unable to continue use.No medical intervention was reported.
Additional Manufacturer Narrative
The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "warning: this is a single use device.Do not reuse.Reuse of a single use device increases the risk of catheter acquired urinary tract infections.Urethral catheter for urological use only.Discard after use, do not resterilize.Made of silicone elastomer.".
Event or Problem Description
It was reported that the eyelets on the magic 3 intermittent catheter, male were not smooth and allegedly caused the patient irritation.The patient was unable to continue use.No medical intervention was reported.

• Brand Name: MAGIC3¿ INTERMITTENT CATHETER
• Common Device Name: MAGIC3 INTERMITTENT CATHETER, MALE
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8088734
• Report Number: 1018233-2018-05529
• Device Sequence Number: 19194219
• 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: consumer,distributor,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2018

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 Expiration Date: 03/28/2023
• Device Model Number: 53618
• Device Catalogue Number: 53618
• Device Lot Number: JUCR0085
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/29/2018
• Supplement Date Received by Manufacturer: 11/28/2018
• Initial Report FDA Received Date: 11/20/2018
• Supplement Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1