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Catalog Number 300865 |
Device Problems
Break (1069); Leak/Splash (1354); Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that syringe 50ml ll was damaged and had air leakage.The following information was provided by the initial reporter: return of blood present in the syringe from the central line, while it was in place in the syringe pump.Cracked syringe? air leak? syringe changed immediately when the nurse enters the room.13/apr/2021 - update according to the reporting department, i can confirm that there were no adverse effects on the patient, and the product that was inside the syringe was not cytotoxic.
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 5/10/2021.H.6.Investigation: one sample and two photos were provided to our quality team for investigation.Through visual inspection, a leakage along the plunger was observed.Upon inspection the syringe, there is no damage or defect within the plunger, the stopper is properly assembled on to plunger, however, the barrel is observed to be damaged.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.As a lot number was unknown for this incident, a device history record review could not be completed.It is possible the damage occurred due to the syringe jamming in the manufacturing equipment.Without a lot code to review device history records, we are not able to properly identify where the damage originated therefore a definitive root cause cannot be determined.
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Event Description
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It was reported that syringe 50ml ll was damaged and had air leakage.The following information was provided by the initial reporter: return of blood present in the syringe from the central line, while it was in place in the syringe pump.Cracked syringe? air leak? syringe changed immediately when the nurse enters the room.On 13/apr/2021 - update: according to the reporting department, i can confirm that there were no adverse effects on the patient, and the product that was inside the syringe was not cytotoxic.
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Search Alerts/Recalls
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