Model Number 365976 |
Device Problems
Leak/Splash (1354); Material Deformation (2976)
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Patient Problem
No Code Available (3191)
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Event Date 02/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: n/a.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 extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
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Event Description
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It was reported that the extenders are too tight with an bd microtainer® tube extender.The following information was provided by the initial reporter: it was reported that extenders are too tight.The extender can be pushed into the microtainer, but it is difficult, and the techs are complaining that the repetitive motion hurts their wrists, so they use a small hammer to push the extender into the microtainer.
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Manufacturer Narrative
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H.6.Investigation: bd had not received samples or photos from the customer facility for evaluation.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to overly tight extenders as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.H3 other text : see h.10.
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Search Alerts/Recalls
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