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

Model Number	325130
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/22/2021
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 eagle inflation device burst when the patient was in surgery with an x-force balloon.
Event or Problem Description
It was reported that the insufflator of the eagle inflation device burst when the patient was in surgery with an x-force balloon.Per additional information via email from ibc on 30oct2021, it was confirmed the eagle injector balloon was broken during filling and also confirmed no patient injury was reported,.
Additional Manufacturer Narrative
The reported event is inconclusive due to poor sample condition.The physical sample was not returned, however, a photo sample was submitted.An evaluation of the photo sample was completed by (b)(6) of atrion medical on (b)(6) 2021 however was unable to evaluate the reported defect without the physical sample.The device was used for treatment, however, it is unknown if it had met relevant specifications or contributed to the reported event.A potential root cause for this event could be, "inadequate design".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: "always follow the manufacturer¿s directions accompanying the balloon dilation catheter for instructions for use, maximum balloon inflation pressure, precautions, and warnings for that device." "before use, inspect the device to verify that no damage has occurred during shipping and handling.".

• Brand Name: BARD® EAGLE® INFLATION DEVICE
• Common Device Name: BARD® 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: yonic anderson ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12605566
• Report Number: 1018233-2021-06313
• Device Sequence Number: 14307612
• Product Code: KOE
• UDI-Device Identifier: 00801741067259
• UDI-Public: (01)00801741067259
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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
• Report Date (Section B): 03/31/2022

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: Lay User/Patient
• Device Expiration Date: 06/30/2022
• Device Model Number: 325130
• Device Catalogue Number: 325130
• Device Lot Number: BMDUAT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/22/2021
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 10/11/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/23/2019
• 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