MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARD® ELLIK EVACUATOR

Catalog Number	000451
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	01/30/2025
Type of Reportable Event	Serious Injury
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 during use, the ellik evacuator disconnected when squeezing to rinse bladder and then splashing surgeon.Per follow up information received via ibc on 05feb2025, stated that the yes, surgeon performing procedure had bodily fluid splash into the face, other staff member had clothing contaminated by bodily fluids from patient.It was unknown what medical intervention provided.
Event or Problem Description
It was reported that during use, the ellik evacuator disconnected when squeezing to rinse bladder and then splashing surgeon.Per follow up information received via ibc on 05feb2025, stated that the yes, surgeon performing procedure had bodily fluid splash into the face, other staff member had clothing contaminated by bodily fluids from patient.It was unknown what medical intervention provided.
Additional Manufacturer Narrative
The reported event was unconfirmed.Visual evaluation of the returned sample noted one opened (without original packaging), used ellik evacuator.Visual inspection of the sample noted attached bulb onto ellik evacuator, applied negative pressure with the tubing into the solution and suction by squeezing onto bulb and slowly releasing.The bulb suctioned with no difficulty and bulb did not disconnect while suctioning.No root cause could be found because the reported event was unconfirmed.A dhr review is not required as the event is unconfirmed, however, one was completed prior to the confirmation.As the reported event is unconfirmed a labeling review is not required.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® ELLIK EVACUATOR
• Common Device Name: ELLIK EVACUATOR
• 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 GA 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 21400897
• Report Number: 1018233-2025-00955
• Device Sequence Number: 8317529
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814(11)240923(17)290131(10)NGJPY102
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: EXEMPT
• 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): 06/18/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 000451
• Device Lot Number: NGJPY102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2025
• Supplement Date Received by Manufacturer: 06/18/2025
• Initial Report FDA Received Date: 02/18/2025
• Supplement Report FDA Received Date: 06/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/23/2024
• 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