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Catalog Number 306572 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Swelling (2091); Reaction (2414)
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Event Date 12/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8179538, medical device expiration date: 2021-06-30, device manufacture date: 2018-06-28.Medical device lot #: 8185572, medical device expiration date: 2021-06-30, device manufacture date: 2018-07-04.Medical device lot #: 8242797, medical device expiration date: 2021-08-31, device manufacture date: 2018-08-30.(b)(6).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 that bd posiflush¿ xs pre-filled flush syringe was used and the patient had a reaction.The patient appeared to be breathless with swelling to both legs.No medical intervention was reported.
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Manufacturer Narrative
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Investigation: 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.No sample available for testing.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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Event Description
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It was reported that bd posiflush¿ xs pre-filled flush syringe was used and the patient had a reaction.The patient appeared to be breathless with swelling to both legs.No medical intervention was reported.
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Search Alerts/Recalls
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