SMITHS MEDICAL ASD, INC. SMITHS MEDICAL ASD, INC.SMITHS MEDICAL ASD, INC.INF SET CLEO 31" 9MM; SET, ADMINISTRATION, INTRAVASCULAR
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Device Problem
Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2020 |
Event Type
malfunction
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Event Description
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Per pt, a large majority of the inf set cleos that she received from us are not disconnecting from her sq site when she tries to change the tubing and therefore, she had to change her sq site 4 times in the month of december alone in order to change the tubing.No adverse events experienced due to defective product.Unknown if patient has defective product on hand for return.Reported to (b)(6) by pt/caregiver.
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