MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® EAGLE® INFLATION DEVICE

Catalog Number	325110
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
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.Udi format updated with available product information per gudid.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 they tried to inflate the balloon dilation catheter with the eagle inflation device, but no pressure was applied.The pressure gauge had come loose.Per follow up information received via ibc on 07oct2024, customer confirmed that patient involvement.
Event or Problem Description
It was reported that they tried to inflate the balloon dilation catheter with the eagle inflation device, but no pressure was applied.The pressure gauge had come loose.Per follow up information received via ibc on 07oct2024, customer confirmed that patient was involved.
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Udi format updated with available product information per gudid.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 they tried to inflate the balloon dilation catheter with the eagle inflation device, but no pressure was applied.The pressure gauge had come loose.Per follow up information received via ibc on 07oct2024, customer confirmed that patient was involved.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted ne inflation device was returned to atrion inside a zip lock bag.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.The glue plug threaded section was found to still be attached to the gauge.The needle on the gauge was also noted to be within the zero position, and the cts mark indicating 100percentage functional inspection at the time of manufacture was present.Functional testing could not be performed on the inflation device due to the gauge being detached from the inflation device body.Also received 3 photo samples.First photo shows two separate pieces of eagle inflation device.Second photo sample shows product label.Third photo sample shows top view of eagle inflation device.No actions can be taken at this time since a root cause was not identified.The 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.Correction- d , h.Udi format updated with available product information per gudid.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.

• Brand Name: BARD® EAGLE® INFLATION DEVICE
• Common Device Name: INFLATION DEVICE
• 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: 20462720
• Report Number: 1018233-2024-06558
• Device Sequence Number: 18083821
• Product Code: KOE
• UDI-Device Identifier: 10801741052696
• UDI-Public: (01)10801741052696(11)220419(17)250228(10)BMGQAT03
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K962611
• 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,Followup
• Report Date (Section B): 01/17/2025

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: 325110
• Device Lot Number: BMGQAT03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 12/23/2024; 01/18/2025
• Initial Report FDA Received Date: 10/16/2024
• Supplement Report FDA Received Date: 01/15/2025; 01/28/2025
• 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