Catalog Number 306572 |
Device Problems
Nonstandard Device (1420); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Sepsis (2067)
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Event Date 08/06/2020 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the patient is fighting sepsis.The patient's mother is wondering if the recalled bd posiflush¿ xs pre-filled flush syringe nacl 0.9% could be contributing to the infection.The following information was provided by the initial reporter: chap0349, 306572, pfs 0.9%p/flush xs saline 10 ml st 9248167.Patient¿s mother reports the patient has been in hospital fighting line sepsis, patient¿s mother would like to know if this could be related to the pfs recall.9248167 is the only recalled batch sent to the patient.
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Manufacturer Narrative
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H.6.Investigation summary a device history record review was performed for provided lot number 9248167 and the review did not reveal any quality issues that could have contributed to this reported incident.The lab testings were reviewed for this lot number and all test results for this product met the standard requirements for intended use prior to release.There is no evidence that the posiflush syringe would have been responsible for an infection.Our quality team will closely monitor the production process for any signs of potential defects or emerging trends.
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Event Description
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It was reported that the patient is fighting sepsis.The patient's mother is wondering if the recalled bd posiflush¿ xs pre-filled flush syringe nacl 0.9% could be contributing to the infection.The following information was provided by the initial reporter: chap0349 306572 pfs 0.9%p/flush xs saline 10ml st 9248167 patient¿s mother reports the patient has been in hospital fighting line sepsis, patient¿s mother would like to know if this could be related to the pfs recall.9248167 is the only recalled batch sent to the patient.
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Search Alerts/Recalls
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