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

Model Number	998606
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/20/2020
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 could not increase on the x-force device.Reportedly, when the inflation device was connected to the x-force and the handle was rotated, a noise occurred and the pressure could not increase.
Additional Manufacturer Narrative
The reported event was confirmed as use-related.Therefore, the device met specifications.The device was being used for treatment.The evaluation report of the returned sample, submitted by atrion medical, stated that during functional testing, the device would not draw water and but instead heard air pulling in, the device leaked from the o-ring/clamp area and would not build pressure, because the o-ring was dislocated and blown out of its assembled position.When the o-ring was removed and replaced with a new one, the device passed the pressure leak, pressure decay, and vacuum capability tests with no leaking observed.Due to the gauge being off zero as received, the device failed the gauge accuracy portion of the functional testing.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: ¿description: the bard® eagle¿ inflation device is a one-piece, plastic, 10cc disposable inflation device with a lock lever design that controls the piston, a pressure gauge, and a high-pressure connecting tube with a male rotating adapter.The pressure gauge measures pressures ranging from vacuum to 30 atm; the gauge is marked in 1 atm increments.The gauge also has an inner scale of comparable psi measurements.The accuracy of the pressure gauge has been determined to be within 1 atm over the range.Indications: the inflation device is recommended for use while performing urological balloon dilation procedures to inflate the balloon, sustain pressure, monitor pressure within the balloon, and deflate the balloon.Contraindication: none.Warnings: ¿ use only liquid inflation media.Do not inflate with air.¿ 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.¿ this is a single use device.Do not re-sterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.Warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable regulations.Precaution: ¿ before use, inspect the device to verify that no damage has occurred during shipping and handling.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.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." 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.
Event or Problem Description
It was reported that the pressure could not increase on the x-force device.Reportedly, when the inflation device was connected to the x-froce and the handle was rotated, a noise occurred and the pressure could not increase.It was later reported from the internatioanal business center via email 13feb2020 that it was in fact the eagle inflation device not functioning correctly.
Event or Problem Description
It was reported that the pressure could not increase on the x-force device.Reportedly, when the inflation device was connected to the x-froce and the handle was rotated, a noise occurred and the pressure could not increase.It was later reported from the internatioanal business center via email 13feb2020 that it was in fact the eagle inflation device not functioning correctly.
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
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9687212
• Report Number: 1018233-2020-00893
• Device Sequence Number: 18985113
• Product Code: KOE
• UDI-Device Identifier: 10801741052719
• UDI-Public: (01)10801741052719
• 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: distributor,other
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/30/2020

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: 06/30/2021
• Device Model Number: 998606
• Device Catalogue Number: 325110
• Device Lot Number: BMCZFM21
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2020
• Initial Date Received by Manufacturer: 01/24/2020
• Supplement Date Received by Manufacturer: 02/13/2020; 03/24/2020
• Initial Report FDA Received Date: 02/10/2020
• Supplement Report FDA Received Date: 02/19/2020; 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1