H6.Investigation summary: "bd had not received samples or photos for investigation.Therefore, 10 retention samples from bd inventory were evaluated by visual examination and no issues were observed relating to damaged barrel as all samples met specifications.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.This complaint is unable to be confirmed for the indicated failure mode damaged barrel.Bd was not able to identify a root cause for the indicated failure mode".H3 other text : see h.10.
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It was reported when using the bd preset¿ syringe with attached needle customer found the needle barrel was broken.The following information was provided by the initial reporter.The customer stated: "when the nurse was taking arterial blood collection for the patient in the ward, when he opened the package of the arterial blood collection device, he found that the needle barrel was broken, resulting in no negative pressure, so that it could not be used".
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