Model Number 192-N251S |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that 1 mckesson prevent sg was unable to deliver medication.The following information was provided by the initial reporter : it was reported by the distributor that it is difficult to push medication through the needle.Date of event : unknown.
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Manufacturer Narrative
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H.6.Investigation: it was reported that it is difficult to push medication though the needles.A device history record review was completed for provided material number 306616, columbus needle lot numbers 1214992, 1278946, 1214008, 1214997.These needle lots were used in the manufacturing of the final product lots 1341422.The review revealed there was documentation for this type of defect during the production run of lot number 1214992 for clogged needles due to silicone.It could be possible these samples are escapes from the incident that occurred while producing batch 1214992.The process to isolate affected product was reviewed, as well as the process of variations that could induce the needle clogged / blocked symptom.The processes were adjusted to prevent variations that could result in this defect.Based on the investigation with device history record analysis the symptom reported by the customer is confirmed.
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Event Description
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It was reported that 1 mckesson prevent sg was unable to deliver medication.The following information was provided by the initial reporter : it was reported by the distributor that it is difficult to push medication through the needle.Date of event : unknown.
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Search Alerts/Recalls
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