Catalog Number 320749 |
Device Problem
Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd ultra-fine¿ micro pen needle experienced an insufficient cannula length on the patient end.The following information was provided by the initial reporter: consumer stated she is bruising as a result of using pen needles.Stated, the ones in the box are too short and not 6mm.Stated pen needles in the box are 3mm because she measured it.
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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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Manufacturer Narrative
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H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.H3 other text : see h10.
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Event Description
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It was reported that the bd ultra-fine¿ micro pen needle experienced an insufficient cannula length on the patient end.The following information was provided by the initial reporter: consumer stated she is bruising as a result of using pen needles.Stated, the ones in the box are too short and not 6mm.Stated pen needles in the box are 3mm because she measured it.
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Search Alerts/Recalls
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