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

Model Number	53618
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/18/2021
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 no liquid came out of the silver pouch to activate the coating, when the patient crushed the silver pouch before opening.
Additional Manufacturer Narrative
The reported event was confirmed as a manufacturing related.Visual evaluation noted 2 unopened magic3 intermittent catheters were received.Visual inspection noted that neither the water packet was burst but both the packets containining no water.No water or residue was found in the catheter package on return.The product had failed to meet the specifications.Although the reported event was confirmed a root cause for the failure mode was unable to determine.However a potential root cause for this failure mode could be due to a mechanical failure.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling review was not performed due to the labeling could not have prevented the reported failure.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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that no liquid came out of the silver pouch to activate the coating when the patient crushed the silver pouch before opening.

• Brand Name: MAGIC3 INTERMITTENT CATHETER
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11317747
• Report Number: 1018233-2021-00434
• Device Sequence Number: 790518
• Product Code: KOD
• UDI-Device Identifier: 00801741068591
• UDI-Public: (01)00801741068591
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K000723
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/09/2021

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: 04/28/2025
• Device Model Number: 53618
• Device Catalogue Number: 53618
• Device Lot Number: JUES1540
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2021
• Initial Date Received by Manufacturer: 01/18/2021
• Supplement Date Received by Manufacturer: 06/09/2021
• Initial Report FDA Received Date: 02/11/2021
• Supplement Report FDA Received Date: 07/01/2021
• 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: Other