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

Model Number	000451
Medical Device Problem Code	Component Misassembled (4004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/23/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there was an unknown issue with the ellik evacuator.The additional information had been requested.Per follow-up information received via ibc on 21jun2021, it was stated that the seal did not close properly, and this item could not be used.It was confirmed that the device was an ellik bladder evacuator.It was also confirmed that there was no patient involved during this issue (ngcx1558).Per the sample received on (b)(6) 2022, it was noted that the customer returned an additional lot (ngcu3572).
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Additional Manufacturer Narrative
The reported event was unconfirmed because the reported failure could not be reproduced.No root cause could be found because the reported event was unconfirmed.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.As the reported event was unconfirmed a labeling review was not required.Correction: g, h 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.H3 other text : the actual/suspected device was inspected.
Event or Problem Description
It was reported that there was an unknown issue with the ellik evacuator.The additional information had been requested.Per follow-up information received via ibc on 21jun2021, it was stated that the seal did not close properly, and this item could not be used.It was confirmed that the device was an ellik bladder evacuator.It was also confirmed that there was no patient involved during this issue (ngcx1558) per the sample received on 23aug2022, it was noted that the customer returned an additional lot (ngcu3572).

• Brand Name: BARD® ELLIK EVACUATOR
• Common Device Name: ELLIK EVACUATOR
• 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: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 15327647
• Report Number: 1018233-2022-06803
• Device Sequence Number: 6362140
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (Y/N): N
• Initial Reporter Country: SF
• 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): 02/14/2023

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: 07/31/2023
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGCU3572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/23/2022
• Supplement Date Received by Manufacturer: 02/15/2023
• Initial Report FDA Received Date: 08/31/2022
• Supplement Report FDA Received Date: 02/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2018
• 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