Catalog Number 306572 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Dyspnea (1816); Itching Sensation (1943); Rash (2033)
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Event Date 07/04/2018 |
Event Type
Injury
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Manufacturer Narrative
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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¿ xs pre-filled flush syringe when used to administered normal saline flush after changing the patient's bionectar, the patient seemed to have an adverse reaction with various symptoms including a rash on her arms, itchiness and difficulties in breathing.There was no report of exposure.
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Manufacturer Narrative
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Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: required intervention; hospitalization.Device single use?: no.Device returned to manufacture: no.Investigation summary: lot number 8081834 for product 306572 was provided for evaluation by our quality engineer.A device history record review did not reveal any issues during the production of lot number 8081834 that could have contributed to the reported issue.All tests results for the provided lot number were reviewed and no non-conformances were found.Samples were not available for return for this incident and retained samples of the same lot number were not available within the manufacturing facility.There is no evidence to support that the posiflush syringe was responsible for the reported reaction.A potential contributory factor may have been the other medicinal products in use or administered at the time the patient's port was flushed with the posiflush product.Complaints for this lot and issue will be closely monitored.
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Event Description
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It was reported that the bd posiflush¿ xs pre-filled flush syringe when used to administered normal saline flush after changing the patient's bionectar the patient seemed to have an adverse reaction with various symptoms including a rash on her arms, itchiness and difficulties in breathing.There was no report of exposure.
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Search Alerts/Recalls
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