Catalog Number 306546 |
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 02/15/2023 |
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.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 bd posiflush¿ normal saline syringe had difficult plunger movement during use.The following information was provided by the initial reporter: "i was given a syringe with a different lot number that exhibits the same difficulties in administering.".
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Manufacturer Narrative
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H6: investigation summary it was reported the plunger does not expel all of the saline in the syringe.To aid in the investigation, one empty sample with no packaging flow wrap or tip cap was received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The sample was then tested for sustaining force per it287, which is the force applied to the plunger rod while moving downwards when expelling the saline solution, and the result was within specification.A device history record review was completed for provided material number 306546, lot 2263292.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed and a probable root cause could not be offered.
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Event Description
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It was reported that the bd posiflush¿ normal saline syringe had difficult plunger movement during use.The following information was provided by the initial reporter: "i was given a syringe with a different lot number that exhibits the same difficulties in administering.".
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Search Alerts/Recalls
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