MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® EAGLE® INFLATION DEVICE; 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	09/23/2024
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.Udi format updated with available product information per gudid.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 the ureteral stricture was encountered during ureteral stone surgery using a ureteroscopic balloon dilation catheter, which was unpacked with the pressurized pump found to be broken.The procedure was completed with a replacement set of balloons.
Event or Problem Description
It was reported that the ureteral stricture was encountered during ureteral stone surgery using a ureteroscopic balloon dilation catheter, which was unpacked with the pressurized pump found to be broken.The procedure was completed with a replacement set of balloons.
Additional Manufacturer Narrative
The reported event is confirmed cause unknown.Visual evaluation noted visual inspection of the device revealed that the right clamp was still attached to the left clamp in both screws, however it was fractured along its entire length.The lower portion is shifted off-position and wedged diagonally against the housing, indicating extreme pressure was applied when the clamp snapped in half.Functional evaluation noted functional testing per wi 91639 could not be performed, as the device was not able to hold liquid without it leaking out through the cracked right clamp opening.Also received 2 photo samples.First photo sample shows top view of outer product packaging.Second photo sample shows side profile of balloon dilation catheter and eagle inflation device.The potential failure mode is product damaged upon arrival.The potential root cause is inappropriate package design.No actions can be taken at this time since a root cause was not identified.Labelling review is not required as labelling would not have prevented the reported event.Dhr review did not show any problems or conditions that would have contributed to the reported event.Correction: d, g, h udi format updated with available product information per gudid.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.

• 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
• 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: 20406513
• Report Number: 1018233-2024-06367
• Device Sequence Number: 6479784
• Product Code: KOE
• UDI-Device Identifier: 00801741067242
• UDI-Public: (01)00801741067242(11)220928(17)241007(10)BMGWAT02
• 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): 01/16/2025

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: 10/07/2024
• Device Catalogue Number: 325110
• Device Lot Number: BMGWAT02
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/23/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/23/2024
• Supplement Date Received by Manufacturer: 01/16/2025
• Initial Report FDA Received Date: 10/09/2024
• Supplement Report FDA Received Date: 01/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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