Model Number 328468 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/30/2023 |
Event Type
malfunction
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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.H3.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 relion insulin syringes plunger rod was difficult to move.This is 2 of 2 related events.The following information was provided by the initial reporter: consumer reported that there is liquid in the syringes, he stated that when depresses the plunger rod, liquid comes out of the syringe.Consumer also reported that the plunger rod is difficult to move.
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Event Description
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It was reported that the relion insulin syringes plunger rod was difficult to move.This is 2 of 2 related events.The following information was provided by the initial reporter: consumer reported that there is liquid in the syringes, he stated that when depresses the plunger rod, liquid comes out of the syringe.Consumer also reported that the plunger rod is difficult to move.
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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) 0.5ml 31ga 8mm syringe, reporting plunger difficult to move.The syringe was visually inspected and observed no physical damages.A functionality test was performed on the plunger, and no issues related to the plunger being difficult to move were observed.Based on the sample returned, embecta was not able to confirm the customer-indicated failure.A review of the device history record was completed for batch# 2213872.All inspections and challenges were performed per the applicable operations qc specifications.The root cause cannot be determined, as the reported failure could not be confirmed.H3 other text : see h10.
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Search Alerts/Recalls
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