MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 UNKNOWN URINE COLLECTION; URINE COLLECTION DEVICE

Catalog Number	Z10
Medical Device Problem Code	Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2026
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 a customer was experiencing issues with the urine meter drain bag tubing kinking.The tubing was kinking at the point where it connected to the meter.This issue had not been personally encountered previously; however, it was also acknowledged that not all complaints are reported directly.It was suggested that the customer check how the bags were being stored to ensure that storage conditions were not creating a ¿memory¿ in the tubing.
Event or Problem Description
It was reported that a customer was experiencing issues with the urine meter drain bag tubing kinking.The tubing was kinking at the point where it connected to the meter.This issue had not been personally encountered previously; however, it was also acknowledged that not all complaints are reported directly.It was suggested that the customer check how the bags were being stored to ensure that storage conditions were not creating a ¿memory¿ in the tubing.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Photo sample evaluation: received 1 photo sample for evaluation.The photo shows a meter drain bag with urine filled; there was a kink in tube where it connects to drain bag.As per the photo, the reported event is confirmed cause unknown.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be" incorrect assembly operation" however, there was insufficient information to confirm this potential root cause.A labeling review could not be performed since no material number was provided.The device history record review could not be performed without a lot number.Corrections made to tab(s) d.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.

• Brand Name: UNKNOWN URINE COLLECTION
• Common Device Name: URINE COLLECTION DEVICE
• 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: 24823520
• Report Number: 1018233-2026-02327
• Device Sequence Number: 9686714
• Product Code: KNX
• UDI-Device Identifier: 00801741033100
• UDI-Public: (01)00801741033100
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Date (Section B): 05/06/2026

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: Other
• Device Catalogue Number: Z10
• 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: 04/03/2026
• Supplement Date Received by Manufacturer: 05/06/2026
• Initial Report FDA Received Date: 04/08/2026
• Supplement Report FDA Received Date: 05/17/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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