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

Model Number	53818G
Medical Device Problem Code	Product Quality Problem (1506)
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.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity.No patient injury reported.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation noted 30 unopened magic3 go's in original box packaging were received.No damage was noted on the exterior of the packaging.No obvious defects were noted.Samples were tested, coefficient of friction was performed.Each sample was cut in half in order to test as a pair.Kinetic cof was found to be within specification ( <0.400) for all catheters tested.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: ¿inspect the catheter before use." h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that the magic 3 catheter had a lack of lubricity.No patient injury reported.

• Brand Name: MAGIC3 GO¿ INTERMITTENT URINARY 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: 8768973
• Report Number: 1018233-2019-03704
• Device Sequence Number: 13880044
• Product Code: EZD
• UDI-Device Identifier: 00801741136986
• UDI-Public: (01)00801741136986
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K172247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/26/2019

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 Expiration Date: 08/28/2021
• Device Model Number: 53818G
• Device Catalogue Number: 53818G
• Device Lot Number: JUCW0126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2019
• Initial Date Received by Manufacturer: 06/18/2019
• Supplement Date Received by Manufacturer: 07/09/2019
• Initial Report FDA Received Date: 07/08/2019
• Supplement Report FDA Received Date: 07/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1