MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY

Catalog Number	903014A
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during the pre-test, the foley tray syringe could not be removed, and when tried to pull it out forcefully, the syringe broke off at the base.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.This report references a us equivalent device.The us udi equivalent for this product number is used.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.
Additional Manufacturer Narrative
The reported event was confirmed ¿ cause unknown.The product had caused the reported failure.Based on the evaluation, it was observed that the syringe tip broken.The broken tip part was not returned.However, the exact cause of how and when problem occurred could not determine.Further investigation has been documented under scar-24-06-001.A potential root cause for this failure could be defect generated at supplier's site or could be contributed by user related during handling the product.Pfmea (b)(4) rev 36 (medical kit packaging and cartoning process) was reviewed for this investigation and has addressed in step/item # 13.A potential root cause for this failure mode could be due to defective / torn / broken components.Based on information in the fmea, the risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.A review of the device labeling have been conducted for investigation purposed.The ifu is attached on the investigation overview element.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore, no additional action required at this time.Correction: d, e, h this report references a us equivalent device.The us udi equivalent for this product number is used.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 during the pre-test, the foley tray syringe could not be removed, and when tried to pull it out forcefully, the syringe broke off at the base.
Additional Manufacturer Narrative
The reported event was confirmed: cause unknown.The product had caused the reported failure.Based on the evaluation, it was observed that the syringe tip broken.The broken tip part was not returned.However, the exact cause of how and when problem occurred could not determine.Further investigation has been documented under scar-24-06-001.A potential root cause for this failure could be defect generated at supplier's site or could be contributed by user related during handling the product.Pfmea ra87p040 rev 37 (medical kit packaging and cartoning process) was reviewed for this investigation and has addressed in step/item # 13.A potential root cause for this failure mode could be due to defective/torn/broken components.Based on information in the fmea, the risk of this failure is low.Current controls in place are adequate to mitigate this failure mode.A review of the device labeling has been conducted for investigation purposed.The ifu is attached on the investigation overview element.A review of the device history record did not show any problems or condition that would have contributed to the reported issue.Therefore, no additional action required at this time.This report references a us equivalent device.The us udi equivalent for this product number is used.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 during the pre-test, the foley tray syringe could not be removed, and when tried to pull it out forcefully, the syringe broke off at the base.Based on the clarification received on 06aug2025, the reported issue was that the syringe could not be detached from the valve after the pretest, and the syringe tip broke.There was no mention that water could not be withdrawn.

• Brand Name: BARDEX® I.C. COMPLETE CARE® URINE METER FOLEY TRAY
• Common Device Name: FOLEY TRAY
• 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: 22327989
• Report Number: 1018233-2025-05017
• Device Sequence Number: 15528978
• Product Code: MJC
• UDI-Device Identifier: 00801741019869
• UDI-Public: (01)00801741019869(11)241220(17)270628(10)MYJW3259
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K910318
• 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,Followup
• Report Date (Section B): 08/07/2025

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: 903014A
• Device Lot Number: MYJW3259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/06/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/06/2025
• Supplement Date Received by Manufacturer: 07/18/2025; 08/07/2025
• Initial Report FDA Received Date: 06/25/2025
• Supplement Report FDA Received Date: 07/18/2025; 08/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/20/2024
• 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