Model Number 324912 |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/29/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd veo¿ insulin syringe with the bd ultra-fine¿ needle was unable to inject insulin.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no.".
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 08-may-2023 h6: investigation summary the customer returned (1) 1.0ml g 31 ga 6mm syringe, reporting difficult to operate (not drawing).The syringe was visually examined under microscope and observed no damages to the cannula.A functionality test was performed on the returned sample and no issues related to drawing was observed.Based on the sample received and visual examination, embecta was not able to confirm the reported failure.A review of the device history record was completed for batch# 2227496.All inspections and challenges were performed per the applicable operations qc specifications.Based on the sample received, embecta was not able to duplicate or confirm the customer-indicated failure.The root cause cannot be determined, as the reported failure could not be confirmed.H3 other text : see h10.
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Event Description
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It was reported that the bd veo¿ insulin syringe with the bd ultra-fine¿ needle was unable to inject insulin.The following information was provided by the initial reporter: "1st plunger issue -chunk out of the plastic missing, was not able to push insulin in.2nd the needle has a burr, extra chunk on needle and cant come off.Some metal deformation.Injury- no".
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Search Alerts/Recalls
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