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

Catalog Number	000451
Medical Device Problem Code	Wrong Label (4073)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
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 they required further clarification regarding the presence of phthalates in this product 000451.The information provided in 2021 indicated that this product did not contain phthalates.They therefore need to understand how and why the incorrect information was provided.They will have our quality and regulatory teams present in the call who would like to raise some additional questions to help us understand the process.Per mdd this symbol would have been required to be on the label per erc 7.5 as shown below but it was not included for some reason.It could be that the tracked material is not accurate for the end item as it appears to not have pvc or phthalates tracked marked.Therefore, this device would have been considered mislabeled under mdd.Could see where this possibly could be a sa for this type of error and need quality involvement.We have realized that our mdd labels were out of compliance and need to report this complaint.The date of awareness is feb 25, 2025.As this is the date we found that the labels were out of compliance.The original questions came in from a supplier asking about what materials were in our products and this was not reported as a complaint.Please do not contact this supplier as we are taking this through our field action committee and will contact them directly after the decision has been made.The complainant has 25 trays that are mdd.This will be an occurrence of 25 and not 25 separate complaints.

• Brand Name: BARD® ELLIK EVACUATOR
• Common Device Name: ELIK 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, GA 30014 ; 7707846100
• MDR Report Key: 24564119
• Report Number: 1018233-2026-01629
• Device Sequence Number: 13144610
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/14/2026

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 Catalogue Number: 000451
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 05/22/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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