BECTON, DICKINSON AND COMPANY (BD) BD PRESET¿ SYRINGE WITH ATTACHED NEEDLE; BLOOD SPECIMEN COLLECTION DEVICE
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Catalog Number 364314 |
Device Problems
Coagulation in Device or Device Ingredient (1096); Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/04/2022 |
Event Type
malfunction
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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 when using the bd preset¿ syringe with attached needle there was insufficient blood flow through the device and missing additive.The following information was provided by the initial reporter and translated to english.The customer stated: "patients needed to use blood collector to collect artery blood, but the artery blood collector does not automatically draw blood, and there is no anticoagulant, in order to ensure normal blood drawing, medical staff adopted manual blood drawing and manual configuration of heparin anticoagulation.After manual preparation, self-prepared heparin coagulation was found, and then a new arterial blood collector was replaced to carry out arterial blood sampling smoothly.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.The expiry date of the lot number 0175903 was july 2022.This complaint is unable to be confirmed for the indicated failure mode insufficient blood flow / missing anti-coagulant.Bd was not able to identify a root cause for the indicated failure mode.
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Event Description
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It was reported when using the bd preset¿ syringe with attached needle there was insufficient blood flow through the device and missing additive.The following information was provided by the initial reporter and translated to english.The customer stated: "patients needed to use blood collector to collect artery blood, but the artery blood collector does not automatically draw blood, and there is no anticoagulant, in order to ensure normal blood drawing, medical staff adopted manual blood drawing and manual configuration of heparin anticoagulation.After manual preparation, self-prepared heparin coagulation was found, and then a new arterial blood collector was replaced to carry out arterial blood sampling smoothly.".
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