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

Model Number	998804
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	04/21/2022
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 water leaked from the handle part of the balloon dilation catheter and pressure did not applied.Another inflation device was used.
Additional Manufacturer Narrative
The reported event was confirmed as supplier manufacturing related.The inflation device was returned.The device needle was noted to be at the zero position and no visible anomalies were noted.Functional testing was performed, the device was connected to a pressure indicator, and the plunger was pulled to fill the device with distilled water for aspiration.During the prep of the device, displaced water started bypassing the quad ring and entering into the lower part of the device housing.The latch was engaged, and the plunger was rotated clockwise to pressurize the device.As pressure increased the gauge needle responded, however gauge accuracy nor functional testing was able to be performed due to the loss of pressure from the water bypassing the quad ring.A vacuum was pulled on the device and rapid bubbling was noted from the quad ring area.The device was then disassembled for further investigation; as the piston was removed from the device housing, a visual inspection was performed with special attention given to the quad ring area.It was noted that the piston exhibited molding flash around the parting line of the piston.Using the vision system, the flash measured 0.006¿, which exceeds the maximum acceptable allowance.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/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 the water leaked from the handle part of the balloon dilation catheter and pressure did not applied.Another inflation device was used.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 14429700
• Report Number: 1018233-2022-03846
• Device Sequence Number: 17518514
• Product Code: EZN
• UDI-Device Identifier: 10801741052764
• UDI-Public: (01)10801741052764
• 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): 07/26/2022

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: 11/24/2023
• Device Model Number: 998804
• Device Catalogue Number: 998804
• Device Lot Number: BMFUFM20
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/25/2022
• Supplement Date Received by Manufacturer: 07/26/2022
• Initial Report FDA Received Date: 05/18/2022
• Supplement Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2021
• 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