C.R. BARD, INC. (COVINGTON) -1018233 100CC SILICONE CLOSED WOUND SUCTION EVACUATOR WITH ANTI-REFLUX VALVE
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Model Number 0070740 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
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.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.
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Event Description
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It was reported that there was hair on the suction evacuator outside seal and near the qr code, so the customer refrained from using it.
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Manufacturer Narrative
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The reported event was confirmed cause unknown.1 sample were confirmed to exhibit the reported failure.The device had not met specifications.The product was not used for patient treatment.The product caused the reported failure.Visual evaluation of the returned sample noted one unopened (with original packaging), silicone closed wound suction evacuator.Visual inspection of the sample noted a strand of hair on the outer packaging near the packaging label.This does not meet specification, which states "product and package (kit) must be free from visible loose or embedded foreign matter greater than an aggregate total of 0.6mm2 or 1/16¿ in length per tappi dirt estimation chart".A potential root cause for this failure mode could be ¿production areas not following cleaning procedure".A review of the device history record did not show any problems or conditions that would have contributed to the reported issue.The investigation is concluded, and no additional action is required at this time.The instructions for use were found adequate and state the following: ¿bard 100cc silicone closed wound suction evacuator with anti-reflux valve sterilized using ethylene oxide.Not made with natural rubber latex.Do not resterilize.Do not use if package is damaged.Contains or presence of phthalates.Single use.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations.¿ 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.
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Event Description
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It was reported that there was hair on the suction evacuator outside seal and near the qr code , so the customer refrained from using it.
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Search Alerts/Recalls
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