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

Model Number	998504
Medical Device Problem Codes	Moisture Damage (1405); Decrease in Pressure (1490); Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/16/2022
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 pressure on the ureteral dilation balloon catheter indeflator kept decreasing despite of bringing up to 30 atm pressure multiple times.
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 bard 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 bard.
Event or Problem Description
It was reported that pressure on the ureteral dilation balloon catheter indeflator kept decreasing despite of bringing up to 30 atm pressure multiple times.Per follow up information received via ibc on 26feb2022, it was stated that there were no holes or tears in the catheter balloon.The inflation device seemed to have water in the pressure indicator face.
Additional Manufacturer Narrative
The reported event is confirmed supplier manufacturing related.The eagle inflation device was returned with the dilation catheter in the opened package.The gauge indicator was observed to be broken and damaged.The root cause for this event would be error in manufacturing.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event is confirmed supplier manufacturing related a label review is not required.The actual/suspected device was evaluated.
Event or Problem Description
It was reported that pressure on the ureteral dilation balloon catheter indeflator kept decreasing despite of bringing up to 30atm pressure multiple times.Per follow up information received via ibc on 26feb2022, it was stated that there were no holes or tears in the catheter balloon.The inflation device seemed to have water in the pressure indicator face.

• 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 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: 13753473
• Report Number: 1018233-2022-01260
• Device Sequence Number: 4676693
• Product Code: KOE
• UDI-Device Identifier: 00801741067259
• UDI-Public: (01)00801741067259
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K962611
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/19/2022
• 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: 12/30/2023
• Device Model Number: 998504
• Device Catalogue Number: 325130
• Device Lot Number: BMFTFM35
• 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: 02/16/2022
• Supplement Date Received by Manufacturer: 03/16/2022; 07/19/2022
• Initial Report FDA Received Date: 03/13/2022
• Supplement Report FDA Received Date: 04/13/2022; 08/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/02/2021
• 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