BECTON, DICKINSON AND CO. BD POSIFLUSH¿ XS PRE-FILLED FLUSH SYRINGE NACL 0.9%; PRE-FILLED SYRINGE
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Catalog Number 306572 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Urinary Tract Infection (2120); Reaction (2414); Alteration In Body Temperature (2682)
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Event Date 01/20/2019 |
Event Type
Injury
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Manufacturer Narrative
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There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8270683, medical device expiration date: 2021-08-31, device manufacture date: 2018-09-27.Medical device lot #: 8242797, medical device expiration date: 2021-08-31, device manufacture date: 2018-08-30.(b)(6).Device evaluated by mfr: a device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
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Event Description
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It was reported that after use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% patient had a reaction and there was medical intervention.The following information was provided by the initial reporter: we have been informed of the following adverse event on (b)(6) 2019 whereby patient reported to be unwell (experiencing high temperature) - reading 39c.Patient stopped feed on the morning of (b)(6) 2019 due to symptoms and attend local a&e for assessment.Following assessment re: blood / urine tests; blood results were clear, however patient had a suspected uti and as a result was administered a stat dose of iv antibiotics.Further information has since been obtained following full assessment; patients blood results were normal, crp normal, chest was clear, and leukocytes present in urine.Port site assessed and no signs of infection.Patient shows sign of a general infection and uti - nothing to suggest a systemic infection.
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Event Description
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It was reported that after use of the bd posiflush¿ xs pre-filled flush syringe nacl 0.9% patient had a reaction and there was medical intervention.The following information was provided by the initial reporter: we have been informed of the following adverse event on (b)(6) 2019 whereby patient reported to be unwell (experiencing high temperature) - reading 39c.Patient stopped feed on the morning of (b)(6) 2019 due to symptoms and attend local a&e for assessment.Following assessment re: blood / urine tests; blood results were clear, however patient had a suspected uti and as a result was administered a stat dose of iv antibiotics.Further information has since been obtained following full assessment; patients blood results were normal, crp normal, chest was clear, and leukocytes present in urine.Port site assessed and no signs of infection.Patient shows sign of a general infection and uti - nothing to suggest a systemic infection.
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Manufacturer Narrative
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Investigation summary: the non-conformances were reviewed for this batch, and there was no record of non-conformance which could contribute to the complaint verbatim reported by the customer.There is no evidence that posiflush syringe was responsible for this reaction.A potential contributory factor maybe other medicinal products in use or administered at the time the patient¿s port was flushed.Conclusion(s): based on the information provided, it is more probable than not that the symptoms described may be an allergic reaction; however, it is highly improbable that this reaction was produced by the normal saline in the bd posiflush product.During the period 2017-2019, there are no other adverse customer complaint trends for the complaint category of allergic reaction, apart from fresenius kabi uk.There are no known allergies to normal saline, either topical or within the body.It is most likely that whatever fluid was in the iv line prior to flushing contained inadequately flushed medication or glucose from previous treatments.
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Search Alerts/Recalls
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