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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL; WOUND DRAIN

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C.R. BARD, INC. (COVINGTON) -1018233 RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL; WOUND DRAIN Back to Search Results
Catalog Number 0070740
Device Problems Disconnection (1171); Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); 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.The device was not returned.
 
Event Description
It was reported that the bulb of the evacuator disconnected from the tubing.There was no reported patient impact or injury.Per follow up with the user facility by email on (b)(6) 2018, the evacuator was connected to a zimmer flat drain and they were not compatible.When the evacuator was connected with a bard flat drain the evacuator worked fine.
 
Manufacturer Narrative
The device was not returned for evaluation.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: ¿vii.Instructions for use: 1.The surgeon should irrigate the wound with sterile fluid and then suction the irrigating fluid and gross debris from the operative site.2.Tubes should lie flat and in line with the anticipated skin exit.To facilitate later removal by manual traction, the tubing should not be curled, pinched, or sutured internally.3.Positioning of the drain in the body cavity, as well as the number of drains indicated, should be determined by the surgeon.4.Drain tubing should be placed within the wound by approximating the areas of critical fluid collection.5.Care must be taken to ensure that all drain perforations or channels lie completely within the wound or cavity to be drained.6.Taping or a triple loop suture (around and not through the tubing) will aid in preventing accidental drain placement.7.Deep drainage is best accomplished by using one or more drains for each level of tissue.Each level should be evacuated by a separate vacuum source.8.Care must be exercised to avoid damage to the drain (refer to warnings).The tubing should be repeatedly checked during closure for free motion to avoid breakage and/or fragment retention within the wound.9.When using a trocar please follow these instructions: 9.I.) with one drain: - draw drain using trocar from inside to outside of wound.- ensure that perforated section of the drain is within the critical fluid collection areas of wound.- remove trocar only by cutting the drain one inch from the end of the trocar.- trim non-perforated section of drain to desired length.- attach non-perforated section of drain either to an evacuator inlet port or to a y-connector.9.Ii.) with two single drains: - follow instruction # 9.I for each of the two drains separately.9.Iii.) with a double drain: - draw drain using trocar from inside to outside of wound.- ensure that desired perforated region of the drain is within the critical fluid collection areas of wound.- cut the outer portion of the drain (outside the wound area) in the middle of the perforated region.Attach non-perforated section of the inserted drain to an evacuator inlet port or to a y-connector.- after cutting (as mentioned above), the second half of this drain can be used separately.If you are not using the second half then dispose of it as per the hospital protocol." 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 bard.
 
Event Description
It was reported that the bulb of the evacuator disconnected from the tubing.There was no reported patient impact or injury.Per follow up with the user facility by email on nov 6, 2018, the evacuator was connected to a zimmer flat drain and they were not compatible.When the evacuator was connected with a bard flat drain the evacuator worked fine.
 
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Brand Name
RELIAVAC CLOSED WOUND SUCTION EVACUATOR, 100ML SILICONE EVACUATOR WITH ANTI-REFL
Type of Device
WOUND DRAIN
Manufacturer (Section D)
C.R. BARD, INC. (COVINGTON) -1018233
8195 industrial blvd
covington GA 30014
MDR Report Key8065119
MDR Text Key127093982
Report Number1018233-2018-05344
Device Sequence Number1
Product Code GCY
UDI-Device Identifier00801741049569
UDI-Public(01)00801741049569
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 12/13/2018
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 Catalogue Number0070740
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 10/22/2018
Initial Date FDA Received11/13/2018
Supplement Dates Manufacturer Received11/26/2018
Supplement Dates FDA Received12/13/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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