Catalog Number 328418 |
Device Problems
Difficult to Remove (1528); No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 07/18/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
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Event Description
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It was reported that during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
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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: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.
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Manufacturer Narrative
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H.6.- complaint evaluation / complaint history check for the event(s) that occurred.A complaint history check was performed and this is the 1st related complaint for difficult/unable to operate and plunger rod difficult to move on lot # 7219705.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.A review of the device history record was completed for batch# 7219705.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200709105, 200708576] noted that did not pertain to the complaint.There was one (1) notification [200708781] noted for smeared stoppers.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 root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Based on the investigation, no additional investigation and no capa is required at this time.
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Event Description
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It was reported that during use of the bd insulin syringe with bd ultra-fine¿ needle, during injection, insulin does not come out of syringe.Consumer also stated that with some syringes, the plunger rod is difficult to move during the injection and before the injection.There was no report of exposure, serious injury or medical intervention.
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Search Alerts/Recalls
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