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

Model Number	325110
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	09/16/2019
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 liquid was leaking from the device.The balloon did not inflate.
Additional Manufacturer Narrative
The reported event was confirmed, as use-related.Evaluation report of the returned sample, submitted by atrion medical, states that during functional testing, the device would not draw water and could hear 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 in, 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: ¿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.".
Event or Problem Description
It was reported liquid was leaking from the device.The balloon did not inflate.

• 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: 9174758
• Report Number: 1018233-2019-06408
• Device Sequence Number: 16667508
• Product Code: KOE
• UDI-Device Identifier: 00801741067242
• UDI-Public: (01)00801741067242
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2019

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: 325110
• Device Catalogue Number: 325110
• Device Lot Number: BMCUAT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Received by Manufacturer: 09/17/2019
• Supplement Date Received by Manufacturer: 11/25/2019
• Initial Report FDA Received Date: 10/10/2019
• Supplement Report FDA Received Date: 12/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1