Catalog Number 324909 |
Device Problem
Contamination (1120)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/05/2018 |
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.Medical device expiration date: n/a.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 bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male.Event attributed to: other.Device single use?: no.Device returned to manufacture: no.
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Event Description
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It was reported that bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.
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Event Description
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It was reported that bd insulin syringe with bd ultra-fine¿ needle had foreign matter or "moisture" in the syringe.No serious injury or medical intervention reported.
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Manufacturer Narrative
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Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 7268719 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for foreign matter on lot # 7268719.Based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
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Search Alerts/Recalls
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