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

Model Number 000451

Device Problem Component Misassembled (4004)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/24/2021

Event Type  malfunction  

Manufacturer Narrative

The reported event was inconclusive.No sample was returned for evaluation.A potential root cause for this failure could be due to ¿misaligned base".The device history record was reviewed and found nothing that could have caused or contributed to the reported event.Labeling review was not required because labeling could not have prevented the reported issue.

Event Description

It was reported that there was an unknown issue with ellik bladder evacuator.Per follow-up information received via ibc on 21jun2021, stated that the seal did not close properly and this item could not be used.The device is ellik bladder evacuator.Patient was not involved during this issue.

Manufacturer Narrative

The reported event was unconfirmed because the reported failure could not be reproduced.The device met relevant specifications.The product was not used for patient treatment.The product had not caused the reported failure.Visual evaluation of the returned sample noted six unopened (with original packaging), disposable ellik evacuators.Visual inspection of the sample noted that the six ellik evacuators was packaged assembled and all components connecting properly without issues.This device is within specification.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.Labeling review was not required as the reported event was unconfirmed.The actual/suspected device was inspected.

Event Description

It was reported that there was an unknown issue with ellik bladder evacuator.Per follow-up information received via ibc on 21jun2021, stated that the seal did not close properly and this item could not be used.The device is ellik bladder evacuator.Patient was not involved during this issue.

• Brand Name: BARD® ELLIK EVACUATOR
• Type of Device: ELLIK BLADDER 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: juan velez ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 12584069
• MDR Text Key: 274972713
• Report Number: 1018233-2021-06244
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (y/n): N
• Reporter Country Code: SF
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/23/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGCX1558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2021
• Initial Date FDA Received: 10/06/2021
• Supplement Dates Manufacturer Received: 09/23/2022
• Supplement Dates FDA Received: 09/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other