CARDINAL HEALTH YANKAUER REGULAR CAPACITY BULB; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Model Number 8888505016 |
Device Problem
Suction Problem (2170)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/13/2022 |
Event Type
malfunction
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Event Description
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The customer reported that they have discovered that the yankauers being stocked all have the same reference number, but some have holes in them and some do not.The blue ones they used to stock never had holes, you simply plug it into the suction tubing and it works.The one with the hole, however, does not suction adequately unless you put your finger over the hole.Additional information received on (b)(6) 2022 stated that the issue was found during patient use however the quantity of involved patients is unknown and no individual incident information is available.There were no known injuries or harm.The customer further stated that this is the model of yankauers they have always used.
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Manufacturer Narrative
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An investigation is currently underway.Upon completion, the results will be forwarded.
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Manufacturer Narrative
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The device history record for lot number 2128512164 was reviewed, and no abnormal process conditions were present during the manufacturing of the product that could have led to the reported issue.The dhr showed that all acceptance criteria inspections per established sampling levels were within acceptable limits during the production process.Two samples were received for evaluation, one from the reported lot number and one representative sample from lot 2109607864.A visual inspection of the received samples was carried out according to the procedure.The representative sample from lot 2109607864 meets specifications however the sample from the reported lot number 2128512164 did not meet specifications; the reported issue was confirmed.A corrective and preventive action has been initiated to address the reported issue.
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