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

Model Number	998810
Medical Device Problem Codes	Failure to Infuse (2340); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/21/2022
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.
Event or Problem Description
It was reported that the foley catheter balloon pressure did not rise due to a defective syringe.It was stated that only the syringe was recovered.As per follow-up information received via ibc on (b)(6) 2022, it was stated that the syringe in the description means the inflation device.
Event or Problem Description
It was reported that the foley catheter balloon pressure did not rise due to a defective syringe.It was stated that only the syringe was recovered.Per follow-up information received via ibc on 09dec2022, stated that the syringe in the description means the inflation device.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.The eagle inflation device was returned without the original packaging.Photo samples of the inflation device were received, however, could not be evaluated for the reported failure.A visual inspection was conducted upon receipt of the device.The device was returned inside a plastic bag with a white crystalized substance on the gauge housing, from use on the patient.The device exhibited a green substance in the glue plug and hose, possible the inflation medium.It was also noted that the gauge needle was inside of the zero position box.The complaint device was connected to a pressure indicator, and the plunger was pulled to fill the device with distilled water for aspiration.Next, the latch was engaged and the plunger was rotated to pressurize the device.As the pressure of the device increased, water started to bypass the quad ring and seep into the lower part of the housing.However, the device was able to build and hold pressure and was within tolerance at 4, 14, and 30atm with moderate resistance.Functional testing continued with the vacuum capability test.Water was pulled into the complaint device and a vacuum was created by pulling the plunger outward.Once the vacuum was created, 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 complaint 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 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.A label/pack review is not required as a review of the label could not have prevented the reported event.H11: section a through f - the information provided by bard represents all of 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 bard.H3 other text : the actual/suspected device was evaluated.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: BALLOON DILATION 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15986385
• Report Number: 1018233-2022-09536
• Device Sequence Number: 5710276
• Product Code: EZN
• UDI-Device Identifier: 10801741052788
• UDI-Public: (01)10801741052788
• 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): 03/28/2023

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: 998810
• Device Catalogue Number: 998810
• Device Lot Number: BMFTFM40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 03/29/2023
• Initial Report FDA Received Date: 12/15/2022
• Supplement Report FDA Received Date: 03/30/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/21/2021
• 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