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Catalog Number 21-7220-24 |
Device Problem
Retraction Problem (1536)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2021 |
Event Type
malfunction
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Event Description
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It was reported that during the placement, the needle did not retract.No consequence for patient but risk for the nurse.No patient injury was reported.
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Manufacturer Narrative
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The returned sample was received decontaminated without its original packaging.A test could not be performed due to the fact that the one sample received for evaluation was previously used and according to instructions for use, any attempt to reprocess the device for subsequent re-use may adversely affect the integrity of the device or lead to deterioration in performance.After sample evaluation, the complaint was not confirmed.No corrective actions were taken since complaint was not confirmed.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.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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