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

Catalog Number	900016A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Short Fill (1575)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/09/2025
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.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 the when the product was opened, the contents of the syringe containing sterile water were leaking, and there was almost no water in the syringe.
Additional Manufacturer Narrative
The reported event was confirmed ¿ supplier related.The product had caused the reported failure.Based on the evaluation, observed there was no water left inside the syringe.Cap was attached at the syringe tip and the plunger was located at 8ml.Visual inspection noted the gasket was collapse and not in the correct location.Removed the plunger and observed there was a piece of plastic part trapped inside the gasket.The reported event is confirmed related to supplier.However, scar issuance would not be initiated since the adverse trend of complaints reported for the same failure mode are less than 3 incidents within a 12-month period.One complaint with the new failure mode will be considered as an outlier¿s complaint and will be monitored and trended by the supplier team.A potential root cause for this failure could be defect generated at supplier's.The labeling and instructions for use were found to be adequate.A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.Complete initial reporter facility name: (b)(6) hospital.Correction: d, e, f, 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 the when the product was opened, the contents of the syringe containing sterile water were leaking, and there was almost no water in the syringe.

• Brand Name: BARDEX® I.C. COMPLETE CARE® 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: 21917885
• Report Number: 1018233-2025-03047
• Device Sequence Number: 18413602
• Product Code: MJC
• UDI-Device Identifier: 00801741019371
• UDI-Public: (01)00801741019371(11)241123(17)270428(10)MYJV5604
• Combination Product (Y/N): Y
• Initial Reporter Country: JA
• PMA/510(K) Number: K040658
• 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
• Report Date (Section B): 07/16/2025

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: 900016A
• Device Lot Number: MYJV5604
• 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: 04/09/2025
• Supplement Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 07/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2024
• 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