BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER; INTRAVASCULAR CATHETER
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Model Number 381823 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 06/09/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone #: (b)(6).A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a defect in the filter, causing fluid leakage.The following information was provided by the initial reporter, translated from portuguese: "one unit of the batch had a defect in the filter, causing fluid leakage.¿.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09aug2022.Bd received a used catheter from an unknown lot for evaluation.The catheter was received in an open package and not the original product packaging.A review of the device history record was performed for the reported lot, 1111254, and no quality issues were found during production.Our quality engineer visually inspected the returned catheter and identified that the catheter was not a bd product.Also, two photos of the defect were provided but not enough evidence was visible in the provided photos to determine any possible defects.Therefore, based off the visual inspection the engineer could not verify this as a manufacturing defect.Since, the defect was determined to not be a bd product a definitive root cause could not be determined.The manufacturing facility has been notified of this incident and the findings.Were received at bd juiz de fora on 09-aug2022, 01 sample used, containing only the catheter, in open packaging and not original product.The sample was received by the person responsible for the analysis and sent for decontamination.According to the visual analysis of the samples, it can be seen that the catheter sent by the customer is not a bd product.H3 other text : see h.10.
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Event Description
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It was reported that the bd insyte¿ autoguard¿ shielded iv catheter had a defect in the filter, causing fluid leakage.The following information was provided by the initial reporter, translated from portuguese: "one unit of the batch had a defect in the filter, causing fluid leakage.¿.
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