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It was reported that the trocars on the bard drains were dull and dangerous.In addition, the same issue was found with the same drains used at georgetown facility.Per follow up via email on 24nov2020, as trocar has been inserted with extreme difficulty and patient needed restitching of fascia that came apart while attempting to insert trocar.All issue occurred during surgical procedure.No extra intervention required apart from extra stitches.
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It was reported that the trocars on the bard drains were dull and dangerous.In addition, the same issue was found with the same drains used at georgetown facility.Per follow up via email on 24nov2020, as trocar has been inserted with extreme difficulty and patient needed restitching of fascia that came apart while attempting to insert trocar.All issue occurred during surgical procedure.No extra intervention required apart from extra stitches.
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The reported event was unconfirmed since the problem could not be reproduced.Visual evaluation of the returned sample noted two opened (with original packaging), used wound drain tubing with wound drain and trocar attached.Visual inspection of the samples noted no obvious visible defects, such as bends or distortions.The trocars appeared to be sharp.This meets the specification as the "trocar point tip and all edges: shall be sharp, free of burrs, nicks and distortion, bent points are not allowed.".No root cause could be found because the reported event was unconfirmed.The lot number was unknown; therefore, the device history record could not be reviewed.The instructions for use were found adequate and state the following: "indications: wound drains are used to remove exudates from wound sites.Warning: when placing drain(s) care should be taken to ensure that the perforated portion of the wound drain lies completely within the confines of the wound.Read product insert provided with the closed wound evacuator for detailed instructions, warnings and precautions associated with the use of the evacuator device.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 for free motion during closure to minimize the 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.¿ surgical removal may be necessary if drain is difficult to remove or breaks.Drain placement 1.Place perforated wound drain within the critical fluid collection area of wound.2.Draw non-perforated section of wound drain through to the outside until drain indicator mark appears at the skin surface.Two sets of indicator marks aid placement of the drain.3.Remove trocar only by cutting the drain one inch from end of trocar.4.Trim non-perforated section of drain to desired length.For bard® 100cc silicone and reliavac® 100 evacuators single drain placement 1.Remove adapter with connector from pouch.2.Insert adapter end into non-perforated section of drain.3.Insert connecting tube of drain to adapter port of evacuator.For two drain placement for bard® 100cc silicone evacuators 1.Attach second drain to adapter.2.Attach connecting tube of both silicone drains to the bard® y-connector (#0070790) and connect y-connector to evacuator drain port.For reliavac® 100 (use blue adapter in drain package and y-connector in evacuator package) 1.Cut off plug from closed arm of y-connector.2.Remove blue adapters from pouches.Insert into y-connector.3.Attach both drains to blue adapters.For reliavac® 400 and 3-spring evacuators single drain placement 1.Ensure open end of y-connector is open or cut to 1/4¿ mark.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach drain to blue adapter.For two drain placement 1.Cut off plug from closed arm of y-connector.2.Remove blue adapter from pouch.Insert into y-connector.3.Attach both drains to blue adapters.Reuse precaution: this is a single use device.Do not re-sterilize 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." the actual/suspected device was inspected.
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