Catalog Number 306546 |
Device Problem
Device Markings/Labelling Problem (2911)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/22/2024 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.H3 other text : see h10 manufacture narrative.
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Event Description
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Material #: 306546 batch#: 3323885 it was reported by customer that the unlabeled syringes mixed in with labelled syringes.Verbatim: rcc received a complaint via email.Email(s) attached.We received several boxes of bd posiflush normal saline flush syringes (0.9% sodium chloride injection, usp), ndc 08290-3065-46 which contained unlabeled syringes mixed in with labelled syringes.
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Manufacturer Narrative
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(b)(4) follow up: a device history record review was completed by our quality engineer team for provided material number 306546 and lot number 3323885.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
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Event Description
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No additional information received material #: 306546 , batch#: 3323885.It was reported by customer that the unlabeled syringes mixed in with labelled syringes.Verbatim: rcc received a complaint via email.Email(s) attached.We received several boxes of bd posiflush normal saline flush syringes (0.9% sodium chloride injection, usp), ndc (b)(4) which contained unlabeled syringes mixed in with labelled syringes.
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Search Alerts/Recalls
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