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

Model Number	998504
Medical Device Problem Codes	Inflation Problem (1310); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/23/2022
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.The information provided by bard represents all of the known information at this time.
Event or Problem Description
It was reported that the pressure in the ureteral dilation balloon catheter did not raise even when the pressure was applied by inflation.It was stated that there was no problem when the separate inventory was opened and used.
Event or Problem Description
It was reported that the pressure in the ureteral dilation balloon catheter did not raise even when the pressure was applied by inflation.It was stated that there was no problem when the separate inventory was opened and used.Per follow up information received via ibc on 14jul2022, it was stated that the customer did not provide any information whether there were any holes or tears in the foley catheter balloon.Per notification received from investigator on 30sep2022, it was stated that during evaluation it was found that the gauge needle was out of the zero position and the gauge was found to be broken at the glue plug area due to shock damage.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Photo samples were submitted which show the gauge broken off the device.The eagle inflation device was returned without the original packaging.An evaluation of the physical sample was completed.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.Based on the results of the investigation no additional action is required at this time.A label/pack review is not required as a review of the label could not have prevented the reported event.The actual/suspected device was inspected.

• 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: 14982445
• Report Number: 1018233-2022-05333
• Device Sequence Number: 5194860
• 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): 12/16/2022

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: 07/31/2024
• Device Model Number: 998504
• Device Catalogue Number: 998504
• Device Lot Number: BMFVAT01
• 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: 06/23/2022
• Supplement Date Received by Manufacturer: 12/17/2022
• Initial Report FDA Received Date: 07/11/2022
• Supplement Report FDA Received Date: 12/20/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/13/2021
• 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