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	11/21/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the foley catheter balloon was unable to inflate during procedure, noticed that gauge is stuck at 4 tried to inject more contrast, however the meter area detached from the indeflator.
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.The eagle inflation device and balloon dilation catheter were returned without the original packaging.An evaluation was completed by nicole bentley of atrion medical.Root cause analysis : the investigation revealed that the uv bond of the glue plug of the complaint device may not have been fully cured therefore atrion has confirmed this complaint.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.A label/pack review is not required as the event is confirmed supplier manufacturing related.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 the foley catheter balloon was unable to inflate during procedure, noticed that gauge is stuck at 4 tried to inject more contrast, however the meter area detached from the indeflator.

• 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: 15932349
• Report Number: 1018233-2022-09363
• Device Sequence Number: 4347726
• Product Code: EZN
• UDI-Device Identifier: 10801741052672
• UDI-Public: (01)10801741052672
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K050875
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2023

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: 998504
• Device Catalogue Number: 998504
• Device Lot Number: BMGTFM21
• 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: 11/21/2022
• Supplement Date Received by Manufacturer: 04/05/2023
• Initial Report FDA Received Date: 12/07/2022
• Supplement Report FDA Received Date: 04/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/28/2022
• 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