Catalog Number 0070430 |
Device Problem
Device Operates Differently Than Expected (2913)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 12/14/2016 |
Event Type
malfunction
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Manufacturer Narrative
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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.The device was not returned.
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Event Description
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It was reported that the white part of the drain was not fusing to the clear tubing, and allegedly pulled the tissue.No patient impact or injury to the patient was reported.
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Manufacturer Narrative
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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.
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Event Description
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It was reported that the white part of the drain was not fusing to the clear tubing, and allegedly pulled the tissue.No patient impact or injury to the patient was reported.
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Manufacturer Narrative
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Received 1 used silicone flat drain with the original unit packaging.Per the visual inspection, no defects were found.However, per the tactile evaluation.It was noted that the white part was not completely posted to the clear tube at the end of the white part.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "¿ 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.Surgical removal may be necessary if drain is difficult to remove or breaks." 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.
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Event Description
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It was reported that the white part of the drain was not fusing to the clear tubing, and allegedly pulled the tissue.No patient impact or injury to the patient was reported.
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Manufacturer Narrative
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Received 1 used silicone flat drain with the original unit packaging.Per the visual inspection, no defects were found.However, per the tactile evaluation.It was noted that the white part was not completely posted to the clear tube at the end of the white part.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: "¿ 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.Surgical removal may be necessary if drain is difficult to remove or breaks." (b)(4).
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Event Description
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It was reported that the white part of the drain was not fusing to the clear tubing, and allegedly pulled the tissue.No patient impact or injury to the patient was reported.Per medwatch: during the surgery the 7mm flat hubless silicone drain was noted to not be fused at the white part.There was no harm to the patient, no excessive blood loss, and no delay in the case.
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Search Alerts/Recalls
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