MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE; RELIA VAC

Catalog Number 0070800

Device Problems Partial Blockage (1065); Obstruction of Flow (2423)

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

Event Date 08/10/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the drain tube was clogged up during usage.The device was replaced.

Manufacturer Narrative

The reported event was unconfirmed due to the lack of a blockage in the tubing.The visual evaluation of the returned sample noted one opened (no original packaging present), used evacuator with significant dried bodily fluid deposits visible on the evacuator balloon and within the tubing.However, there was not enough of a deposit to cause blockage or clogging.The tubing was placed in the water reservoir.Suction and flow was observed, but the device only suctioned 300ml of water, which was considered out of specification.After removing the balloon, no obvious perforations or cracks were observed in the latex surface.The inner and outer straightener was confirmed to be present.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "important: a.Check for fluid entering reliavac® evacuator.Lack of flow may indicate the following: i.All exudates have been removed.Ii.Wound drain is clogged and may require irrigation & aspiration (consult physician).Iii.Auxiliary wall suction pressure is above 210 mm hg.Iv.Deflated balloon: check all connections for air leak and drain perforations for exposure above the skin and follow step ¿11¿ above.If still deflated, replace the evacuator.B.When not using auxiliary suction during surgical wound closure, several activations of the reliavac® evacuator may be required to establish suction because of the following: i.Air entering partially closed wound.Ii.An operative air pocket.".

Event Description

It was reported that the draine tube was clogged up during usage.The device was replaced.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE, 35" (88.9CM) STERILE
• Type of Device: RELIA VAC
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 7894811
• MDR Text Key: 120999643
• Report Number: 1018233-2018-04317
• Device Sequence Number: 1
• Product Code: GCY
• UDI-Device Identifier: 00801741049606
• UDI-Public: (01)00801741049606
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup
• Report Date: 12/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2018
• Date Manufacturer Received: 12/07/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1