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

Model Number	998004
Medical Device Problem Codes	Material Fragmentation (1261); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2023
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.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.
Event or Problem Description
It was reported that manometer section of inflation device was broken off.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Four photo samples were submitted and the eagle inflation device within original packaging and balloon dilation catheter were returned.One photo samples showed the product packaging with identifiers, two photo samples showed the inflation device with the gauge completely detached from the body.The fourth photo showed the balloon portion of the dilation catheter with no apparent non-conformities noted.It was noticed that the gauge was broken off from the inflation device body at the glue plug area.The needle on the gauge was noted to be within the zero position, and functional testing was unable to be conducted on the inflation devices due to the gauge being detached from the inflation device body.An inspection of the gauge was conducted which indicated some portions of the solvent bond to be slightly tacky and possibly not fully cured.Using a torque meter the gauge was un-torqued from the glue plug fragments with an off force of 24.85 in.Lb which is within the acceptance value of = 15 in.Lb.The gauge also did not exhibit any signs of over compression onto the inflator body and it passed the thread start verification inspection.The daily uv curing log was reviewed on the day of manufacture for this lot.It indicates all readings were within specifications.A potential root cause could be the uv bond of the glue plug of the complaint device may not have been fully cured therefore atrion has confirmed this complaint.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.Correction- d, f, h 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 manometer section of inflation device was broken off.

• 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: 16814593
• Report Number: 1018233-2023-02872
• Device Sequence Number: 5733921
• Product Code: EZN
• UDI-Device Identifier: 10801741052795
• UDI-Public: (01)10801741052795
• 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): 07/21/2023

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: 12/08/2024
• Device Model Number: 998004
• Device Catalogue Number: 998004
• Device Lot Number: BMGUFM16
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/04/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/04/2023
• Supplement Date Received by Manufacturer: 07/21/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 08/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2022
• 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