MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® EAGLE® INFLATION DEVICE; EAGLE INFLATION DEVICE 10CC/ 30 ATM

Model Number	325110
Medical Device Problem Code	Inflation Problem (1310)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/07/2019
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 was found to be damaged upon opening the package.The pump leaked during pretest.
Event or Problem Description
It was reported that the eagle inflation device was found to be damaged upon opening the package.The pump leaked during pretest.
Additional Manufacturer Narrative
The reported event was inconclusive as no sample was returned for evaluation.A potential root cause of the reported event could be hose assembly/device connection leaks due to which the pump leaked during pretest.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: "instructions for use: preparation: make all aspiration and injection maneuvers with the lock lever pushed left, i.E., unlocked.Unlock the piston by pushing the lock lever left.In this position, you can freely pull the piston back for aspiration, or push it forward for injection.To lock the piston in position, slide the lever right to the straight up position.1.Prepare a solution of contrast medium and normal saline in a small sterile bowl or in the well provided with the package.Check balloon catheter and contrast medium instructions for specific contrast mixture recommendations.2.Orient the tubing downward into the contrast medium.3.Push the release lever left and aspirate enough solution to fill the syringe.4.Hold the device upright to purge the air from the syringe and connecting tube.Tap the syringe lightly, if necessary, to remove all the air bubbles and fill the connecting tube completely.5.Inspect the syringe and tubing to ensure that the device has been completely purged.6.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.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.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." h11:section a through f - the information provided by bd represents all of 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.H3 other text : the device was not returned.
Event or Problem Description
It was reported that the eagle inflation device was found to be damaged upon opening the package.The pump leaked during pretest.
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 of 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 10CC/ 30 ATM
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9671927
• Report Number: 1018233-2020-00758
• Device Sequence Number: 11406724
• 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: company representative,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/17/2020

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: 04/30/2020
• Device Model Number: 325110
• Device Catalogue Number: 325130
• Device Lot Number: BMBRAT01
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/16/2020
• Supplement Date Received by Manufacturer: 02/26/2020; 03/12/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/09/2020; 03/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1