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

Catalog Number	153509
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/10/2025
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.Initial reporter phone: (b)(6).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 four of the drainage bags customer received have damaged and defective tubes.They have provided photos which have been uploaded in the notes in our system, and are available if you should need them.The photos show that the tubes have kinks, crimps, dents, and warped areas.They have requested replacements.The customer is retaining the four items in case the manufacturer requests them.We have already replaced the product for our customer.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned seven-photo sample noted one opened (without original packaging), used dome drainage bag.Visual inspection of the sample noted that the first, second and third photo shows the drainage tubes with kinks.The fourth, fifth, sixth and seven photo shows the drainage tubing with crimps and dents.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 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 four of the drainage bags customer received have damaged and defective tubes.They have provided photos which have been uploaded in the notes in our system, and are available if you should need them.The photos show that the tubes have kinks, crimps, dents, and warped areas.They have requested replacements.The customer is retaining the four items in case the manufacturer requests them.We have already replaced the product for our customer.Per follow up information received via email on 18nov2025, it was reported that the sample is no longer available.The item was purchased for a 100 yr-old male.The patient did not use the faulty item.There was a kink in the tubing.No medical intervention was required.

• Brand Name: BARD® URINARY DRAINAGE BAG
• Common Device Name: 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: 23064977
• Report Number: 1018233-2025-08168
• Device Sequence Number: 21252926
• Product Code: KNX
• UDI-Device Identifier: 00801741029608
• UDI-Public: (01)00801741029608(11)250516(17)300331(10)NGKR2399
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/26/2026

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: 153509
• Device Lot Number: NGKR2399
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 09/16/2025
• Supplement Report FDA Received Date: 03/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/16/2025
• 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: Male