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

Model Number 53616GS

Device Problems Shipping Damage or Problem (1570); Expiration Date Error (2528)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event 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.

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 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
• Type of Device: MAGIC3 HYDROPHILIC INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11285152
• MDR Text Key: 230480613
• Report Number: 1018233-2021-00296
• Device Sequence Number: 1
• Product Code: OHR
• UDI-Device Identifier: 00801741072666
• UDI-Public: (01)00801741072666
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 06/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 06/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other