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

Model Number 000451

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Date 03/11/2020

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 rubber on the ellik bladder evacuator became loose during use.

Manufacturer Narrative

The reported event could not be confirmed.It was unknown whether the device met specifications since no sample was returned for evaluation.The product was used for treatment purposes.A potential failure mode could be ¿leak¿ with a potential root cause of ¿tubing is damaged or tubing dimensions are not to specification¿.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." h11:section a through f - the information provided by bd 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 bd.H3 other text : the device was not returned.

Event Description

It was reported that the rubber on the ellik bladder evacuator became loose during use.

Manufacturer Narrative

The reported event was confirmed, however the cause was unknown.Visual inspection noted that one ellik evacuator was received with the original opened packaging.Visual evaluation noted that the rubber tube was disconnected from the evacuator on return.Although the reported event was confirmed, the root cause could not be determined.A potential root cause for this failure could be due to tubing not properly secured to reservoir joint.The product used for the treatment purposes.The product would not meet specifications, and was influenced by the reported failure.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: "caution: this product contains natural rubber latex which may cause allergic reactions.Fill with solution.Displace all air before using.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.Caution: federal (usa) law restricts this device to sale by or on the order of a physician.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practices and applicable local, state and federal laws and regulations.Single use.Do not resterilize.Caution, consult accompanying documents.Contains or presence of natural rubber latex.Do not use if package is damaged." correction: b3, d10, h3, h6, h10.H11:section a through f the information provided by bd 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 bd.

Event Description

It was reported that the rubber on the ellik bladder evacuator became loose during use.

• Brand Name: BARD ELLIK EVACUATOR
• Type of Device: DISP ELLIK BLADDER EVACUATOR
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9885452
• MDR Text Key: 186728802
• Report Number: 1018233-2020-02137
• 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: company representative,other
• Type of Report: Initial,Followup,Followup
• Report Date: 08/10/2020

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 Model Number: 000451
• Device Catalogue Number: 000451
• Device Lot Number: NGDW1575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2020
• Initial Date Manufacturer Received: 03/04/2020
• Initial Date FDA Received: 03/26/2020
• Supplement Dates Manufacturer Received: 04/14/2020; 07/21/2020
• Supplement Dates FDA Received: 04/27/2020; 08/10/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1