Catalog Number 329461 |
Device Problems
Break (1069); Difficult to Remove (1528)
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Patient Problem
Foreign Body In Patient (2687)
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Event Date 03/24/2017 |
Event Type
Injury
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Manufacturer Narrative
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A device evaluation is anticipated, but has not yet begun.However, a review of the device history record has been completed and no defects or notifications during manufacturing were identified for the reported lot # 6039545.Conclusion: a conclusion is not yet available as the evaluation is still in progress.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that a 1/2 ml bd lo-dose¿ u-100 insulin syringe with 28 g x 1/2 in.Bd micro-fine¿ iv permanently attached needle broke of in a cat's hip during a spay surgery.The cat received an x-ray and the broken needle was visualized.The doctor is not sure if the needle can be removed and will consult another veterinary surgeon.
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Manufacturer Narrative
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Results: three samples; one loose and two in sealed blister packs were returned for evaluation.All returned syringes were examined and the loose sample exhibited a broken cannula.A microscopic examination of the returned sample with the broken cannula revealed characteristics such as residual bends on the broken hub end, cracked adhesive and tubing ovality (deformation from the normally circular cross section).When viewed together, these are all indicators of bending/re-straightening mode of failure.Removal of some of the adhesive made this observation more apparent.As previously reported, a review of the device history record revealed no defects or notifications during manufacturing for the reported lot # 6039545.Conclusion: an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.
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Search Alerts/Recalls
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