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

Model Number	998810
Medical Device Problem Codes	Material Fragmentation (1261); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the syringe was broken and it was difficult to inflate the balloon of ureteral dilation balloon catheter on the day of use.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Photo samples were provided, however, could not be evaluated for the reported event.The eagle inflation device was received without the original packaging.Per the evaluation results, the root cause confirms that this complaint is due to the excessive flash.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 bd 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 bd.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that the syringe was broken and it was difficult to inflate the balloon of ureteral dilation balloon catheter on the day of use.Per follow-up information received from ibc on 09aug2022, stated that the syringe was the inflation device.Per sample evaluation results received on 11oct2022, it was reported that the gauge needle was out of the zero position when the ureteral dilation balloon catheter was returned.It was stated that when attempting to aspirate, the needle on the gauge increased with the increase in pressure but was out of tolerance due to shock damage or misuse.

• Brand Name: BARD® X-FORCE® BALLOON DILATION CATHETER
• Common Device Name: 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: 15102626
• Report Number: 1018233-2022-05752
• Device Sequence Number: 5255502
• 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): 01/05/2023

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
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/11/2022
• Supplement Date Received by Manufacturer: 01/06/2023
• Initial Report FDA Received Date: 07/26/2022
• Supplement Report FDA Received Date: 01/13/2023
• 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