Catalog Number 328468 |
Device Problem
Break (1069)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 12/09/2019 |
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 an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs experienced the cannula breaking off or pulling out during use, and serious injury in the form of medical intervention.The consumer stated that the cannula broke off beneath the skin and they were unable to pull it out.The consumer sought urgent care, but there is no additional information regarding the outcome of the medical intervention.The following information was provided by the initial reporter: material no: 328468 ; batch no: 8232928.Verbatim: issue(s): needle break off in site (ab) during injection.Does not reuse needles.Unable to pull out on her own.Consumer stated going to the urgent care now.Can see the needle under her skin.Lot #: 8232928.Item #: 328468.Date of event: (b)(6) 2019.
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Manufacturer Narrative
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H.6.Investigation: customer returned one (1) loose 0.5ml bd insulin syringe.Consumer reported needle break off in site (ab) during injection.The returned syringe was examined, and it was observed that the cannula was broken.No evidence of manufacturing defect was observed on the sample.The hub-end of the cannula appeared to have been bent prior to breaking, suggesting a bending and re-straightening mode of failure.Since the syringe was returned after use, and no manufacturing defects were observed, the probable cause of the broken cannula is user error when using the syringe.A review of the device history record was completed for batch# 8232928.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [200772181] noted for adhesive on cannula.There was one (1) notification [200772622] noted that did not pertain to the complaint.H3 other text : see h.10.
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Event Description
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It was reported that an unspecified number of syringe 0.5ml 31ga 8mm ufii 10bag 500cs experienced the cannula breaking off or pulling out during use, and serious injury in the form of medical intervention.The consumer stated that the cannula broke off beneath the skin and they were unable to pull it out.The consumer sought urgent care, but there is no additional information regarding the outcome of the medical intervention.The following information was provided by the initial reporter: material no: 328468; batch no: 8232928.Verbatim: issue(s): needle break off in site (ab) during injection.Does not reuse needles.Unable to pull out on her own.Consumer stated going to the urgent care now.Can see the needle under her skin.Lot #: 8232928; item #: 328468; date of event: (b)(6) 2019.
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Search Alerts/Recalls
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