BECTON, DICKINSON AND CO. BD POSIFLUSH¿ NORMAL SALINE SYRINGES,; SALINE, VASCULAR ACCESS FLUSH
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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 08/24/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd posiflush¿ normal saline syringes, the plunger was difficult to move.This occurred 5 times.There was no report of patient impact.The following information was provided by the initial reporter: we have noticed several saline flushes (bd 0.9% sodium chloride injection) that seem to 'jam up' while being used.Only 2-5 ml will push then the plunger stops working.It can lead to questioning of the iv patency and possible additional iv sticks for the patient if the nurse thinks the iv is bad when it is really the flush.We have disconnected the flush and it still is hard or impossible to depress the plunger.We have had at least 5 reports of defective flushes.
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Manufacturer Narrative
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H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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The reports were from 5 different patient and they were being used as intended, manual flushes.
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Manufacturer Narrative
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To aid in the investigation of this issue, two (2) physical samples were returned for evaluation by our quality engineer team.The two samples had been removed from their flow wrap testing, disassembled, and emptied; therefore, we were unable to confirm the reported defect.Although we could not confirm the issue through the samples, it is possible that this incident resulted from a faulty thermocouple.The thermocouple controls the dispersion of silicone in the syringe barrel.The faulty thermocouple in turn led to intermittent defects which were not detected during the in-process checks.A review of the manufacturing execution system (mes) shows a report of faulty thermocouple during the manufacture of this lot; however, the faulty thermocouple has since been replaced.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
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