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

Catalog Number	325110
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
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.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 upon unpacking the package during the operation, it was found that the pump of the balloon dilation catheter had been broken and damaged, and then it withdrew and replaced with a new packaging product to continue the operation, without adverse effects on the patient.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted one inflation device was returned inside a the inflator tray.Upon receipt of the complaint device a visual inspection was conducted.During the visual inspection, it was noted that the gauge was broken from the inflation device housings at the glue plug area.The needle on the gauge was also noted to be within the zero position.However, functional testing could not be performed on the inflation device due to the gauge being detached from the inflation device body.Also received 1 photo sample.Photo sample shows top view of inflation device with gauge separated from the rest of the device.Based on photo and physical sample received product does not meet specifications.Although an exact root cause could not be determined a potential root cause could be inappropriate package 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: "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." 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 upon unpacking the package during the operation, it was found that the pump of the balloon dilation catheter had been broken and damaged, and then it withdrew and replaced with a new packaging product to continue the operation, without adverse effects on the patient.

• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18039287
• Report Number: 1018233-2023-07742
• Device Sequence Number: 7074025
• 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): 01/16/2024
• 2 Devices were Involved in the Event: 1 2

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: 11/18/2024
• Device Catalogue Number: 325110
• Device Lot Number: BMGQAT03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/25/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/11/2023
• Supplement Date Received by Manufacturer: 01/16/2024
• Initial Report FDA Received Date: 10/31/2023
• Supplement Report FDA Received Date: 01/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/03/2022
• 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