MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG; DRAIN BAG

Catalog Number	154114A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2025
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.Udi format updated with available product information per gudid.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 the foley catheter had a tear upon opening and refrained from use.
Additional Manufacturer Narrative
Upon further review, bd has determined that this mdr is not reportable as it was found there was a sample port breakage which is against drain bag.Submitting the investigation details as additional information.The reported event was confirmed cause unknown.Received (8) photo samples.The first photo sample shows the overview of the drainage bag, sample port and the catheter.The second photo sample the broken sample port connector.Third photo sample shows the inflation valve cap.The fourth photo shows the urine meter.The fifth and sixth photo shows the sheet clip connected to the urine meter.The seventh photo shows the date code.The eight photo shows the product packaging information.Visual inspection: received sample in opened package.Sample was evaluated and found sample port breakage.There were no abnormalities on the others component of the returned package.This does not meet specification which states "no short shots, cracks, voids or breakage are permitted".No actions can be taken at this time since a root cause was not identified.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: direction for use: visually inspect the product for any imperfection or surface deterioration prior to use.If package is opened or damaged or if any imperfection or surface deterioration is observed do not use.1.Remove protective cap from drainage tube catheter adapter and connect drainage tube to the catheter.2.Position hanger on bedside rail near the foot of the bed.3.Use sheeting slip to secure drainage tube sheet.Important: position drainage tube in a straight fashion from catheter to drainage bag.4.To empty bag: a.Remove outlet tube from housing: gently squeeze connector arms and pull tube from housing.B.Release clamp and empty bag.C.After emptying re clamp outlet tube and slide connector into housing until connector arms engage.5.Periodic observation of this system should be made to ensure the urine is flowing freely.If a standing column of urine is observed check for correct positioning of bag and then for physical obstruction.If correct positioning or removal of physical obstruction does not allow free flow, the bag may have to be changed.Correction: b, d, e, g, f, h udi format updated with available product information per gudid.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 the drain bag had a tear upon opening and refrained from use.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: DRAIN BAG
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 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: 21409941
• Report Number: 1018233-2025-01032
• Device Sequence Number: 9382211
• Product Code: KNX
• UDI-Device Identifier: 00801741029547
• UDI-Public: (01)00801741029547(11)241105(17)270428(10)MYJW1904
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: EXEMPT
• 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): 08/05/2025

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: 154114A
• Device Lot Number: MYJW1904
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/14/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 08/12/2025
• Initial Report FDA Received Date: 02/19/2025
• Supplement Report FDA Received Date: 08/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/05/2024
• 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