MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY; DRAIN BAG

Catalog Number	903014A
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was a packaging issue for the drain bag as it was open and not sealed.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: section a through f - the information provided by bd represents all 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.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The reported failure was able to be reproduced.The product was used for urological care.Sample has been evaluated and observed the opening area of the pouch opened.There was a trace of sealing on the clear plastic pouch.Trace line of sealing also observed on the paper side of the pouch- at the back.The cause of the unseal pouch could not be identified.The exact cause of how and when the problem occurred could not be determined.A potential root cause for this failure mode could be due to operator error (rough handling) or user related (rough handling).A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The instructions for use were found adequate and state the following: closed system drainage bag: 2,000 ml.Precision urine meter:350ml.Cautions/warnings: this is a single use product.Do not reuse.This product must be stored in a cool, dry place, away from wet and direct sunlight.Should the package is damaged, do not use the product.This product is sterilized by ethylene oxide gas.Correction: d, e, h.This report references a us equivalent device.The us udi equivalent for this product number is used.H11: section a through f - the information provided by bd represents all 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 there was a packaging issue for the drain bag as it was open and not sealed.

• Brand Name: BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21593708
• Report Number: 1018233-2025-01656
• Device Sequence Number: 15536577
• Product Code: MJC
• UDI-Device Identifier: 00801741019869
• UDI-Public: (01)00801741019869(11)241015(17)290828(10)MYJV6036
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2025

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 Catalogue Number: 903014A
• Device Lot Number: MYJV6036
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2025
• Supplement Date Received by Manufacturer: 05/09/2025
• Initial Report FDA Received Date: 03/13/2025
• Supplement Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown