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	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	01/13/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that water leaked from the manometer.
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 water leaked from the manometer.
Additional Manufacturer Narrative
The reported event is confirmed, supplier manufacturing related.Photo samples were submitted and the physical sample was returned without the original packaging.An evaluation of the physical sample was completed by nicole bentley.Visual evaluation of the photo samples noted the gauge broken off and completely separated from the device body.Visual evaluation of the physical sample noted that the gauge was broken off from the inflation device body at the glue plug area.The needle on the gauge was also noted to be within the zero position.Root cause: 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.

• 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: 16277506
• Report Number: 1018233-2023-00518
• Device Sequence Number: 15201824
• 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): 05/01/2023

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: 02/28/2025
• Device Model Number: 998804
• Device Catalogue Number: 998804
• Device Lot Number: BMGQAT03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 01/16/2023
• Supplement Date Received by Manufacturer: 05/02/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/19/2022
• 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