Catalog Number 324920 |
Device Problem
Physical Resistance (2578)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/28/2017 |
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 the plunger on a 0.5 ml bd insulin syringe with 29 g x 6 mm bd ultra-fine¿ needle was difficult to move and the patient felt resistance while injecting medication.There was no report of injury or medical interventions.
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Manufacturer Narrative
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Investigation: no samples or photos are available for review.A review of the device history record was completed for batch# 4121917.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) defects or notifications noted during production of the above listed batch(es), as noted through device history record review.Without a sample, an absolute root cause for this incident cannot be determined.
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Search Alerts/Recalls
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