Lot number: lot number was reported as unknown, but upon deceive receipt, the lot number was noted as 3802153.Related to mfrs (same patient with multiple occurrences): 3012307300-2019-05555, 3012307300-2019-05556.
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Device evaluation: one bivona sample was received for evaluation in used condition and without its original packaging inside a ziploc bag.Visual inspection found loose contamination on the unit.Next, the sample was filled with 5cc of air for functional testing.When inflating the unit with air, the cuff inflated without problems.No leaks were found.Upon further leak testing the device was inflated, and it was visually inspected for 10 seconds, and observed to be well inflated.Subsequently, the unit was submerged under water, no leakage was observed.Next, the investigator massaged the product and the balloon was squeezed where the airway line moved back and forth, and no leakage was detected.Furthermore, no leaks were found when the device was filled with 5 cc of water.Additionally, the airway line assembly and balloon assembly were reviewed with no discrepancies and were audited during thirty two (32) units finding no deflated/incorrectly inflated cuffs.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence and testing, the complaint was not confirmed.No fault was found with the returned sample.
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