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

Catalog Number	998504
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
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 when opened the product the customer found that the manometer on the eagle inflation device was damaged in the packaging.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted one inflation device was returned to atrion inside its tray.Upon receipt of the complaint device a visual inspection was conducted.During the visual inspection, it was noted that the gauge was broken from the inflation device housings at the glue plug area.Additionally, a crystalized substance was found on various parts of the inflator body and the gauge when the device was received.The glue plug threaded section of the device was broken off from the device and remained attached to the gauge threads.The device exhibits the atrion cts mark, indicating 100 percentage functional verification at the time of manufacture and the gauge needle is within the zero position.The cts testing includes pressure leakage, pressure decay, vacuum capability, gauge accuracy.Functional evaluation noted functional testing could not be performed on the inflation device due to the gauge being detached from the inflation device body.Root cause could not be identified.Although a root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be inappropriate package design.However, there was insufficient information to confirm this potential root cause.A dhr review did not show any problems or conditions that would have contributed to the reported event.Labelling review is not required as labelling would not have prevented the reported event.Udi format updated with available product information per gudid.
Event or Problem Description
It was reported that when opened the product the customer found that the manometer on the eagle inflation device was damaged in the packaging.

• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 19604478
• Report Number: 1018233-2024-03728
• Device Sequence Number: 7326230
• Product Code: EZN
• UDI-Device Identifier: 10801741052672
• UDI-Public: (01)10801741052672(11)220419(17)250228(10)BMGQAT03
• 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): 09/19/2024

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 Catalogue Number: 998504
• Device Lot Number: BMGQAT03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2024
• Supplement Date Received by Manufacturer: 09/19/2024
• Initial Report FDA Received Date: 06/25/2024
• Supplement Report FDA Received Date: 09/20/2024
• 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