ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 21-7302-24 |
Device Problem
Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Visual inspection was performed on pictures received and one sample returned with its original packaging open inside of the plastic bag.Sample was received with white cap loose, complaint is confirmed.He most probable root cause is an accidental oversight during white cap assembly performed by production personnel, the white cap was not fix completely.The following action was taken, awareness notification was performed on (b)(6) 2021 to production personnel about the complaint related to the white cap and slide clamp loose.
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Event Description
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It was reported that when opening the package, the cap was already detached.No patient injury was reported.
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Manufacturer Narrative
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Other, other text: while performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.Report 3012307300-2022-08601 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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