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

Model Number	53616GS
Medical Device Problem Code	Expiration Date Error (2528)
Health Effect - Clinical Codes	No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2021
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 5/28/19, and the actual expiration date indicated in the system was 11/27/22.
Additional Manufacturer Narrative
The reported failure was confirmed as entry error into electronic inventory system when the product was entered into the system.Visual inspection noted 49 unopened magic3 intermittent catheter insertion supply kits were received.Visual evaluation noted that the lot number on the packages is juby0249, and the expiration date listed on the packaging labels is (b)(6) 2019.After investigation, the expiration date error was present in the expiration date on jde, not the product.The product displayed the correct expiration date.The product was shipped expired due to the jde system error.While it was found that the expiration date was incorrectly entered in to jde, a correction to the system is not necessary.Although the reported event was confirmed, a root cause could not be determined.A potential failure mode is an error in jde or an omission from the distributors on review of expiration date before shipping.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not performed because labeling could not have prevented the reported failure.Correction: h.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 the catheter packaging label had the incorrect expiration date as (b)(6) 2019, and the actual expiration date indicated in the system was (b)(6) 2022.Per notification from investigator on (b)(6) 2021, the correct expiration date was placed on the catheter packaging label.It was just shipped to the customer expired.

• Brand Name: MAGIC3 HYDROPHILIC INTERMITTENT CATHETER, MALE
• Common Device Name: INTERMITTENT CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11279648
• Report Number: 1018233-2021-00263
• Device Sequence Number: 11789015
• Product Code: OHR
• UDI-Device Identifier: 00801741072666
• UDI-Public: (01)00801741072666
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 06/03/2021

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: 01/07/2021
• Initial Date Received by Manufacturer: 01/07/2021
• Supplement Date Received by Manufacturer: 06/04/2021
• Initial Report FDA Received Date: 02/04/2021
• Supplement Report FDA Received Date: 06/28/2021
• 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