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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 SILICONE FLAT DRAIN; WOUND DRAINAGE

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C.R. BARD, INC. (COVINGTON) -1018233 SILICONE FLAT DRAIN; WOUND DRAINAGE Back to Search Results
Model Number 0070430
Device Problem Material Fragmentation (1261)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/01/2021
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 wound drain broken during removal.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was confirmed however the cause was unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was used for patient treatment.Visual evaluation of the returned sample noted one opened (without original packaging), used hubless flat wound drain.Visual inspection of the sample noted obvious visible observation of flat wound drain broken on the return photo sample.This is considered a failure, stating that " no damaged or missing components".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: "caution: federal (u.S.A.) law restricts this device to sale by or on the order of a physician.To avoid the possibility of a hematoma due to wound evacuation, the instructions for use should be carefully followed.To avoid the possibility of drain damage or breakage: additional perforations should not be made in the drains.Avoid suturing through drains.Drains should lie flat and in line with the skin exit areas.Particular care should be taken to avoid any obstacles to the drain exit path.Drains should be checked during closure for free motion to avoid possibility of breakage.Drain removal should be done gently by hand.They should not be handled with pointed, toothed or sharp instruments which could cause cuts or nicks and lead to subsequent structural failure of the drain.Warning: surgical removal may be necessary if drain is difficult to remove or breaks.Indications for use: closed wound drainage post head and neck, abdominal, orthopaedic, ent, ob/gyn, plastic surgery.Contraindications: do not use for chest drainage.Warning: do not bypass/inactivate anti-reflux valve.A.Use with single flat drain - 1.Place perforated wound drain within critical fluid collection area of wound.2.Draw drain tube through skin/stab wound incision until flat portion of drain is seated appropriately.3.Trim drain tube to desired length and attach to blue adapter.Connect other end of blue adapter to y-connector.4.Insert connecting tube in reliavac® port a, up to indicator ring.B.Use with two flat drains - 1.Place perforated portion of wound drains within critical fluid collection areas of wound.2.Draw drain tubes through skin/stab wound incision until flat portion of the drains are seated appropriately.3.Trim drain tubes to desired length.4.Cut off plug from closed arm of y-connector and attach blue adapters.5.Attach drains to blue adapters.6.Insert connecting tube in reliavac® port a, up to indicator ring.Caution: punctures or additional perforations should not be made in the silicone wound drain.C.Attaching to auxiliary suction - 1.Insert suction adapter into port b.2.During auxiliary suction, balloon will inflate and exudate will flow over balloon surface from port a to port b.3.To discontinue auxiliary suction, remove suction adapter and close port b.Caution: do not use with wall suction in excess of 210mm hg.D.To establish suction - 1.Open port b.2.Pump bulb until balloon fills container.3.Close port b.Note: hissing sound is normal and stops when maximum suction pressure is reached.Possible reflux of fluid to the patient is reduced during reliavac® evacuator reactivation by a built-in anti-reflux valve in port a.E.To empty container - 1.Open port b.2.Invert unit.3.Pump bulb to empty quickly.F.To re-establish suction - 1.Repeat step "d" above.G.To read fluid volume - 1.Open port b.2.Allow balloon to deflate.3.Read and record volume.4.To reactivate, repeat step "d" above." h11: section a through f - the information provided by bd represents all 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 actual/suspected device was inspected.
 
Event Description
It was reported that the wound drain broken during removal.No medical intervention was reported.
 
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Brand Name
SILICONE FLAT DRAIN
Type of Device
WOUND DRAINAGE
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
yonic anderson
8195 industrial blvd
covington 30014
7707846100
MDR Report Key12532465
MDR Text Key273324658
Report Number1018233-2021-05976
Device Sequence Number1
Product Code GBX
UDI-Device Identifier00801741090752
UDI-Public(01)00801741090752
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Health Professional,User Facility
Reporter Occupation Physician
Type of Report Initial,Followup
Report Date 03/28/2022
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 Model Number0070430
Device Catalogue Number0070430
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/03/2021
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/03/2021
Initial Date FDA Received09/27/2021
Supplement Dates Manufacturer Received03/28/2022
Supplement Dates FDA Received04/21/2022
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
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