The reported event was inconclusive since the photo sample condition was poor.It is unknown whether the device had met relevant specifications.The product was used for patient treatment.It was unknown whether the product had caused the reported failure.Visual evaluation of the returned photo sample noted one opened (without original packaging), used silicone channel drain.Visual inspection of the photo sample noted the channel drain was cut in a piece.This investigation is considered inconclusive due to the photo sample cannot be evaluated for the reported failure.A potential root cause for this event could be ¿incorrect set-up.-incorrect tooling.-incorrect parameters -not enough material.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: ¿instructions for use 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 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.
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