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

Model Number	325110
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/24/2022
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.
Event or Problem Description
It was reported that the pressure pump in the eagle inflation device leaked water when in use by the clinician.It was mentioned that a new pressure pump was used.
Event or Problem Description
It was reported that the pressure pump in the eagle inflation device leaked water when in use by the clinician.It was mentioned that a new pressure pump was used.As per follow up information received via ibc on 15sep2022, it was stated that was no impact to the patient.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned and further evaluation was not conclusive.Although a specific cause cannot be determined, based on the reported event a potential root cause could be that the device was damaged in transit.It was unknown if the device had met all relevant specifications or resulted in the reported event.No manufacturing issues or non-conformances were noted during review of the dhr that could have caused or contributed to the reported event.The instructions for use were found adequate and states the following: "before use, inspect the device to verify that no damage has occurred during shipping and handling." "attaching the inflation device to the balloon dilation catheter: 1.Prepare and test the balloon dilation catheter according to the manufacturer¿s directions for use.2.If a separate syringe was used to prepare the balloon catheter, remove it.Create a fluid-fluid connection between the balloon and the connecting tube (male rotating adapter) of the inflation device by placing a drop of contrast solution from the syringe into each hub.3.Hand tighten the hubs securely." 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: EAGLE 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: 15419689
• Report Number: 1018233-2022-07132
• Device Sequence Number: 12393614
• Product Code: KOE
• UDI-Device Identifier: 00801741067242
• UDI-Public: (01)00801741067242
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K962611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/09/2023

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: 02/29/2024
• Device Model Number: 325110
• Device Catalogue Number: 325110
• Device Lot Number: BMFQAT02
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/05/2022
• Supplement Date Received by Manufacturer: 02/10/2023
• Initial Report FDA Received Date: 09/14/2022
• Supplement Report FDA Received Date: 02/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/14/2021
• 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