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

Model Number	53616GS
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Expiration Date Error (2528)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/08/2021
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 the catheter packaging label had the incorrect expiration date as 05/05/19, and the actual expiration date as per the system was 11/27/22 and had short count shipment.
Additional Manufacturer Narrative
The reported event was inconclusive.Visual inspection noted 49 unopened magic3 intermittent catheter insertion supply kits were received.The result of this investigation is inconclusive as we are unable to determine the number of products received by end customer.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.A labeling review is not required because a review of the label could not have prevented this issue.H11: section a through f - the information provided by bard 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 bard.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the catheter packaging label had the incorrect expiration date as 05/05/19, and the actual expiration date as per the system was 11/27/22 and had short count shipment.

• Brand Name: MAGIC3 HYDROPHILIC INTERMITTENT CATHETER, MALE
• Common Device Name: MAGIC3 HYDROPHILIC INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11285152
• Report Number: 1018233-2021-00296
• Device Sequence Number: 4371621
• Product Code: OHR
• UDI-Device Identifier: 00801741072666
• UDI-Public: (01)00801741072666
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2021

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: Health Professional
• Device Expiration Date: 05/28/2019
• Device Model Number: 53616GS
• Device Catalogue Number: 53616GS
• Device Lot Number: JUBY0249
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2021
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 06/11/2021
• Initial Report FDA Received Date: 02/05/2021
• Supplement Report FDA Received Date: 07/05/2021
• 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