CARDINAL HEALTH SUCTION YANKAUER CLEAR BULB TIP; APPARATUS, SUCTION, OPERATING-ROOM, WALL VACUUM POWERED
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Model Number K86 |
Device Problems
Crack (1135); Suction Failure (4039)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/17/2023 |
Event Type
malfunction
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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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Event Description
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The customer reported the yankauers are cracked, causing loss of suction.Also, there is a sharp jagged edge along the line of the crack that could cause patient harm during use.Per additional information provided on (b)(6) 2023, the yankauers were cracked before use but some of them were not noticed until trying to use them.The staff had to open a few of them until they located one that was not affected.There was no patient harm, only a patient safety issue.
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Manufacturer Narrative
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The device history record was reviewed and indicated that the product was released accomplishing all quality standards.The device was manufactured on (b)(6) 2022.A sample was not received for the investigation.Because a sample was not returned, we were unable to perform functional and visual evaluations to confirm the reported condition and determine the root cause.If a sample is received at a later date, the complaint will be reopened, and the investigation will be updated accordingly.Personnel has been made aware of the reported condition.No further action is applicable at this time.Functional testing and visual inspections are performed according to our current quality standards and inspection procedures.This complaint will be used for tracking and trending purposes.
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Search Alerts/Recalls
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