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Model Number 21-7220-24 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/14/2019 |
Event Type
malfunction
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Event Description
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It was reported that when the cannula was removed, the tubing was bent.Subject noticed that the cannula base was dark in color and stiff.No patient injury was reported.
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Manufacturer Narrative
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One (1) picture was received for evaluation which observed the cannula bent.Production personnel performs 100% visual inspection using a black light in order to verify that drop has been placed at each joint and the amount of adhesive is correct.The most probable root cause is that the product become damaged after it left the manufacturer facilities since the product is 100% tested using the skin adhesive inspection fixture t98-5434.No corrective action is required as there is no information to suggest that the product become damaged during manufacture due to product is 100% visual inspected and tested with the skin adhesive inspection fixture t98-5434.Device history record review found no discrepancies or anomalies.Operator of device patient/consumer this remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).
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Search Alerts/Recalls
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