ST PAUL CADD MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number 21-7302-24 |
Device Problem
Tear, Rip or Hole in Device Packaging (2385)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Event Description
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It was reported that packaging is broken.Slit on the paper side.Material non-sterile.No patient injury was reported.
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Manufacturer Narrative
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A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The product samples were received for evaluation.The six samples were visually inspected.The samples were returned with its original packaging inside in a plastic bag.The six samples presented a damaged pouch, a cut was detected in each sample received.The complaint is confirmed.The root cause of the reported failure can be attributed to manufacturing.
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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 3012307300-2022-08709 is no longer considered reportable, please disregard any mdr reports associated with it.
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Search Alerts/Recalls
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