MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARD® URINE METER WITH BAG

Catalog Number	153204
Medical Device Problem Codes	Fluid/Blood Leak (1250); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/03/2026
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: 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 that there was an issue with the integrity of a foley catheter used that morning (b)(6) 2025.16f bard surestep foley ref (b)(4).There was no obvious issue upon opening the package and initial assessment.When the certified registered nurse anesthetist went to tip the urometer for measurement, urine began spilling out of the top part of the bag.After close and thorough inspection, there was a noted hole or tear in the bag.The doctor was made aware, and foley catheter was to be replaced in the patient post procedure.After additional inspection once the catheter was removed from the patient and comparing it to the replacement catheter, they noticed there was a circle hole in the upper right corner of the bag the new foley had a square white backing inside the bag, blocking the hole that appeared to be missed from the leaking bag.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.Correction: d, f, g, h.Udi format updated with available product information per gudid.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 that there was an issue with the integrity of a foley catheter used that morning 2.3/25.16f bard surestep foley ref # (b)(4).There was no obvious issue upon opening the package and initial assessment.When the certified registered nurse anesthetist went to tip the urimiter for measurement, urine began spilling out of the top part of the bag, after close/thorough inspection, there was a noted hole/ tear in the bag.Doctor of medicine was made aware, and foley catheter was to be replaced in the patient post procedure.After additional inspection once the catheter was removed from the patient and comparing it to the replacement catheter, they noticed there was a circle hole in the upper right corner of the bag the new foley had a square white backing inside the bag, blocking the hole that appeared to be missed from the leaking bag.
Additional Manufacturer Narrative
The reported event was inconclusive because this investigation did not result in any additional findings and no sample was available for evaluation.A dhr could not be performed since no lot number was provided.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 that there was an issue with the integrity of a foley catheter used that morning 2.3/25.16f bard surestep foley ref # a902416.There was no obvious issue upon opening the package and initial assessment.When the certified registered nurse anesthetist went to tip the urimiter for measurement, urine began spilling out of the top part of the bag, after close/thorough inspection, there was a noted hole/ tear in the bag.Doctor of medicine was made aware, and foley catheter was to be replaced in the patient post procedure.After additional inspection once the catheter was removed from the patient and comparing it to the replacement catheter, they noticed there was a circle hole in the upper right corner of the bag the new foley had a square white backing inside the bag, blocking the hole that appeared to be missed from the leaking bag.

• Brand Name: BARD® URINE METER WITH BAG
• Common Device Name: URINE METER WITH 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: 24422224
• Report Number: 1018233-2026-01156
• Device Sequence Number: 10605438
• Product Code: KNX
• Combination Product (Y/N): Y
• 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): 04/29/2026

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: 153204
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/03/2026
• Supplement Date Received by Manufacturer: 02/24/2026; 04/29/2026
• Initial Report FDA Received Date: 02/23/2026
• Supplement Report FDA Received Date: 02/25/2026; 05/03/2026
• 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