BECTON, DICKINSON AND CO. BD¿ POSIFLUSH¿ SALINE XS 10 ML; SALINE, VASCULAR ACCESS FLUSH
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Catalog Number 306572 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Confusion/ Disorientation (2553)
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Event Date 01/06/2023 |
Event Type
malfunction
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Event Description
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It was reported while using bd¿ posiflush¿ saline xs 10 ml an adverse event without an identified device problem occurred.There was no report of patient impact.The following information was provided by the initial reporter: today i got an odd taste in my upper airway and throat, similar to the feeling i get from a ct scan.It was like ether.Today at canberra hospital in australia oncology day ward instead of saline they used a bd posiflush prefilled syringe.With in 30 minutes, i was confused,disorientated, memory loss, i did not know where i was.Went back to the ward and 8 people rushing around saying things like ¿stay with us lynn¿ i could feel myself drifting off.Male nurse who flushed the port said he had another patient with the same issues and ether like taste.He said i looked absolutely dreadful during this frightening event.
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Manufacturer Narrative
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Patient¿s birthday was not provided, (b)(6) 1952 was used based on age of patient.Date of event is unknown; awareness date has been used for this field.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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It was reported while using bd¿ posiflush¿ saline xs 10 ml an adverse event without an identified device problem occurred.There was no report of patient impact.The following information was provided by the initial reporter: today i got an odd taste in my upper airway and throat, similar to the feeling i get from a ct scan.It was like ether.Today at canberra hospital in australia oncology day ward instead of saline they used a bd posiflush prefilled syringe.Within 30 minutes, i was confused,disorientated, memory loss, i did not know where i was.Went back to the ward and 8 people rushing around saying things like ¿stay with us lynn¿ i could feel myself drifting off.Male nurse who flushed the port said he had another patient with the same issues and ether like taste.He said i looked absolutely dreadful during this frightening event.
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Manufacturer Narrative
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H6: investigation summary: a device history record review was completed for provided material number 306572 and lot number 2052102.The review found no possible non-conformances during the production process that could have contributed to this reported incident.All relevant in process and finished product inspections performed during this lot were found to be within specification.These test results ensure that the product was fit for its intended use and met the standard requirements for the product.As samples were unavailable for return, a thorough sample analysis could not be performed.As per product specifications, the composition/ingredients of the 0.9% saline posiflush xs product (material number 306572, lot number 2052102) is sodium chloride dissolved in water for injection, to produce a 0.9% sodium chloride solution.In addition, this product is not made with natural rubber latex or preservatives.This product is non-toxic and non-pyrogenic.
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