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

Model Number 000451

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that the user recently had issues where the end was breaking off from the bulb where the rubber tubing was attached.This tubing was normally pulled off and their own silicone tubing was attached and olympus adaptor, as the surgeons found that the tubing supplied was too flimsy.They had been doing that for years without a problem; however, recently the entire end was breaking off in their hands, leaving the product useless.The reported issue seemed to be related to only one lot number which was removed.There was approximately 4 to 5 discarded before it was realized that this was an issue.There have been no other incidents with the other lot numbers.

Event Description

It was reported that the user recently had issues where the end was breaking off from the bulb where the rubber tubing was attached.This tubing was normally pulled off and their own silicone tubing was attached and olympus adaptor, as the surgeons found that the tubing supplied was too flimsy.They had been doing that for years without a problem; however, recently the entire end was breaking off in their hands, leaving the product useless.The reported issue seemed to be related to only one lot number which was removed.There was approximately 4 to 5 discarded before it was realized that this was an issue.There have been no other incidents with the other lot numbers.

Manufacturer Narrative

The device was not returned for evaluation.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿this is a single use device.Do not resterilize any portion of this device.Reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.".

• Brand Name: BARD® ELLIK EVACUATOR
• Type of Device: ELLIK EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8880879
• MDR Text Key: 154009853
• Report Number: 1018233-2019-04632
• Device Sequence Number: 1
• Product Code: KQT
• UDI-Device Identifier: 00801741080814
• UDI-Public: (01)00801741080814
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 08/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2024
• Device Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGDP1905
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1