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	09/24/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the pressure was applied up to 30 atm by the inflation device of the balloon dilation catheter, but the water leakage occurred from the handle part on the way and no pressure was applied.As per additional information via email from ibc on 22jun2022, it was unknown whether 2 individuals (patients) used same catheter from same lot.As per sample received on (b)(6) 2022, it was noted that an additional inflation device was returned.
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 pressure was applied up to 30 atm by the inflation device of the balloon dilation catheter, but the water leakage occurred from the handle part on the way and no pressure was applied.As per additional information via email from ibc on (b)(6) 2022, it was unknown whether 2 individuals (patients) used same catheter from same lot.As per sample received on 24sep2022, it was noted that an additional inflation device was returned.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Photo samples were submitted, however, no leakage could be seen from the photos.The eagle inflation device was returned without the original packaging.An evaluation of the physical sample was completed.The gauge needle was observed to be in the zero position.An unknown green substance was found inside the housing and glue plug.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.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 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.

• 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: 15526224
• Report Number: 1018233-2022-07594
• Device Sequence Number: 6028992
• 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): 02/21/2023

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: 998804
• Device Catalogue Number: 998804
• Device Lot Number: BMFTFM54
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/24/2022
• Supplement Date Received by Manufacturer: 02/21/2023
• Initial Report FDA Received Date: 10/02/2022
• Supplement Report FDA Received Date: 02/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/23/2021
• 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