MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® X-FORCE® BALLOON DILATION CATHETER; FOLEY CATHETER

Model Number	998504
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	06/22/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that contrast agent leaked from the plunger.The bard x-force ureteral balloon catheter could not be inserted due to ureteral stenosis, and the ureteral stenosis was dilated with a vasodilator balloon.During the procedure, the inflation device attached to the bard x-force ureteral balloon catheter was connected to the vasodilator balloon.When the pressure was raised to 12 atm, the pressure dropped, and the diluted contrast medium leaked from the plunger.The inflation device was used in a way that was not the original combination.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.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, supplier related.Photo samples were submitted which showed some liquid present in the device.The eagle inflation device was returned without the original packaging; an evaluation of the physical sample was completed.The gauge needle was noted to be in the zero position.Functional testing was performed according; the device was connected to a pressure indicator, and plunger pulled to fill the device with distilled water for aspiration.The latch was engaged, and the plunger was rotated clockwise to pressurize the device.As pressure increased, the distilled water started to bypass the quad ring and seeped into the lower part of the device housing.The water bypassing the quad ring prevented the device from building and holding pressure so the device was unable to reach full pressurization.Functional testing continued with the vacuum capability test; water was pulled into the device and a vacuum was created by pulling the plunger outward.Once the vacuum was created, the water again bypassed the quad ring creating rapid bubbling inside the housing of the device.Due to the continual flow of water bypassing the quad ring, functional testing was discontinued and the device was disassembled for further investigation.Upon disassembling the device, molding flash was seen at the parting line on the piston, which attaches to the end of the plunger.This is the area where water was seen bypassing the quad ring during functional testing.The molded flash on the parting line was measured on the vision system at 0.006 inches.The molded flash measured greater than the acceptance criteria and was out of tolerance.The device was used for treatment purposes.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The labeling or packaging review was not required as a review of the label could not have prevented the reported event.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.H3 other text: the actual/suspected device was inspected.
Event or Problem Description
It was reported that contrast agent leaked from the plunger.The bard x-force ureteral balloon catheter could not be inserted due to ureteral stenosis, and the ureteral stenosis was dilated with a vasodilator balloon.During the procedure, the inflation device attached to the bard x-force ureteral balloon catheter was connected to the vasodilator balloon.When the pressure was raised to 12 atm, the pressure dropped, and the diluted contrast medium leaked from the plunger.The inflation device was used in a way that was not the original combination.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14989122
• Report Number: 1018233-2022-05360
• Device Sequence Number: 13856554
• Product Code: EZN
• UDI-Device Identifier: 10801741052672
• UDI-Public: (01)10801741052672
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K050875
• 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): 10/26/2022

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 Expiration Date: 12/30/2023
• Device Model Number: 998504
• Device Catalogue Number: 998504
• Device Lot Number: BMFTFM35
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2022
• Supplement Date Received by Manufacturer: 10/26/2022
• Initial Report FDA Received Date: 07/12/2022
• Supplement Report FDA Received Date: 10/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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