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

Model Number	325130
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2022
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 when the water was injected into the eagle inflation balloon using a pressure pump for inflation, the pressure pump leaked water at the proximal end.The event included an additional surgery or drug therapy, and a new pressure pump was used.Per follow-up information received via ibc on (b)(6) 2022, stated that there was no additional surgery or drug therapy was performed.
Additional Manufacturer Narrative
The reported event is inconclusive because no sample was returned for evaluation.A potential root cause for this event could be, "end plug/body seal leak; gage/end plug interface leaks".The device was used for treatment purposes, however, it is unknown if the device had met all relevant specifications or resulted in the reported event.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." "inspect the syringe and tubing to ensure that the device has been completely purged." "adjust the syringe volume to 3 to 4cc.If more contrast solution is needed, submerge the syringe tip into the basin of solution and aspirate." "balloon inflation and deflation: 1.Release the lock lever and allow the piston to move forward into neutral position (0 atm).2.To inflate the balloon, engage the lock lever, turn the palm grip on the piston clockwise slowly until the desired inflation pressure is reached.The lock lever maintains the increasing pressure.3.To deflate the balloon, push the lock lever left, releasing the piston, and pull back.Slide the lock lever back to lock, if desired." correction: h 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 the water was injected into the eagle inflation balloon using a pressure pump for inflation, the pressure pump leaked water at the proximal end.The event included an additional surgery or drug therapy, and a new pressure pump was used.Per follow-up information received via ibc on (b)(6) 2022, stated that there was no additional surgery or drug therapy was performed.
Event or Problem Description
It was reported that when the water was injected into the eagle inflation balloon using a pressure pump for inflation, the pressure pump leaked water at the proximal end.The event included an additional surgery or drug therapy, and a new pressure pump was used.Per follow-up information received via ibc on 03mar2022, stated that there was no additional surgery or drug therapy was performed.
Additional Manufacturer Narrative
The reported event was unconfirmed as the failure could not be reproduced.The eagle inflation device was returned in the opened original packaging.An evaluation was completed.The gauge needle was in the zero position upon receipt.Functional testing was performed.The complaint device was connected to a pressure indicator, and plunger pulled to fill the device with distilled water for aspiration.No water leakage was seen when prepping the device.The latch was then engaged, and the plunger was rotated clockwise to pressurize the device.As pressure increased, the pressure indicator increased as well.The device was found to be within tolerance at the 4, 14, and 30 atm.Functional testing continued with pressure leak, pressure decay, and vacuum capability testing.No water leakage was found throughout the functional testing.The device was then allowed to sit for approximately six days and was functionally tested for a second time.The device again passed all functional testing without leakage.All inflation devices are sampled, inspected, and accepted.Atrion's current manufacturing controls include 100% automation testing for pressure leakage, pressure decay, vacuum decay, and gauge accuracy during manufacture using ultra high purity nitrogen gas before leaving our facility.At no time is any solution or other substance introduced into the device.Devices that pass this test are marked by automation for identification.Devices that fail are not marked.The returned device was marked, indicating it met manufacturing specifications when it left facility.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required as the reported event was unconfirmed.The actual/suspected device was inspected.

• 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 13795703
• Report Number: 1018233-2022-01363
• Device Sequence Number: 3812867
• Product Code: KOE
• UDI-Device Identifier: 00801741067259
• UDI-Public: (01)00801741067259
• 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,Followup
• Report Date (Section B): 09/20/2022

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: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 325130
• Device Catalogue Number: 325130
• Device Lot Number: BMEWAT01
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 06/09/2022; 09/20/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 06/29/2022; 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2020
• 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