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

Model Number	998806
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/07/2022
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 pump supplied with the x-force u30 ureteroscopic balloon dilation catheter was found to be malfunctioned upon opening of the package and the pointer did not move when pressurizing.It was mentioned that the patient's condition was good and the patient had infectious disease.As per follow up information received via ibc on 15-nov-2022, it was stated that there was no patient involvement.
Event or Problem Description
It was reported that the pump supplied with the x-force u30 ureteroscopic balloon dilation catheter was found to be malfunctioned upon opening of the package and the pointer did not move when pressurizing.It was mentioned that the patient's condition was good and the patient had infectious disease.As per follow up information received via ibc on 15nov2022, it was stated that there was no patient involvement.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample condition.No physical sample was returned; however, a photo sample was submitted.The photo submitted was a still image from a 16 second video, the still image was at the 0 second mark; the eagle inflation device could be seen; however, the gauge needle could not be seen from the angle the device was held and the reported defects could not be evaluated.Although a specific cause cannot be determined, potential root causes for this event could be, "inadequate specifications, inadequate supplier".It is unknown if the device had met relevant specifications or resulted in the reported event.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "before use, inspect the device to verify that no damage has occurred during shipping and handling.Do not exceed 30 atm" 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.

• 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: 15852113
• Report Number: 1018233-2022-08923
• Device Sequence Number: 6525793
• Product Code: EZN
• UDI-Device Identifier: 10801741052771
• UDI-Public: (01)10801741052771
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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: 998806
• Device Catalogue Number: 998806
• Device Lot Number: BMFTFM26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Supplement Date Received by Manufacturer: 03/10/2023
• Initial Report FDA Received Date: 11/23/2022
• Supplement Report FDA Received Date: 03/16/2023
• 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