MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER

Catalog Number	154002
Medical Device Problem Code	Material Too Soft/Flexible (4007)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
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.The reported product number is unknown.The udi number for this product is not available.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 registered nurse reported that complaining that foley tubing softer, bending, kinking more often.The tubing on them was very soft instead of rigid, like the previous ones.So, they were always getting kinked, and it was common to have to drain the foley lift it up to create a back pressure.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.It is unknown whether the device had met relevant specifications.The product was used for urological care.It was unknown whether the product had caused the reported failure.A potential root cause for this failure could be due to tight bundles.Unable to review the labelling due to unknown product code.Although the product family is unknown, the foley catheter ifus are found to be adequate based on past reviews.The dhr review could not be performed without a lot number.Therefore, no additional action is required at this time.Correction: e.The reported product number is unknown.The udi number for this product is not available.H11: sections 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 registered nurse reported that complaining that foley tubing softer, bending, kinking more often.The tubing on them was very soft instead of rigid, like the previous ones.So, they were always getting kinked, and it was common to have to drain the foley lift it up to create a back pressure.
Event or Problem Description
It was reported that registered nurse reported that complaining that foley tubing softer, bending, kinking more often.The tubing on them was very soft instead of rigid, like the previous ones.So, they were always getting kinked, and it was common to have to drain the foley lift it up to create a back pressure.Per additional information received via email on 25sep2025, a bedside nurse noticed these noticeable kinks on the drainage tubing on two of the patients who had just returned from the o.R.One floor nurse made a comment to state has noticed that the tubing seems less stiff compared to before.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned five-photo sample noted one opened (without original packaging), used bard closed system drainage bag with anti-reflux chamber.Visual inspection of the five-photo sample noted a kink on the drainage tubing causing the drainage tubing to become flimsy.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Corrections made to tab(s) d and g.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.

• Brand Name: BARD® URINARY DRAINAGE BAG WITH ANTI-REFLUX CHAMBER
• Common Device Name: URINARY DRAINAGE 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, GA 30014 ; 7707846100
• MDR Report Key: 23031507
• Report Number: 1018233-2025-07942
• Device Sequence Number: 18562447
• Product Code: KNX
• UDI-Device Identifier: 00801741029509
• UDI-Public: (01)00801741029509(11)250606(17)270930(10)NGKS0068
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/13/2026

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: 154002
• Device Lot Number: NGKS0068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2025
• Supplement Date Received by Manufacturer: 09/18/2025; 04/13/2026
• Initial Report FDA Received Date: 09/11/2025
• Supplement Report FDA Received Date: 09/22/2025; 04/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/06/2025
• 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