Investigation summary: bd had not received samples, but three (3) photos were provided for investigation.The photos were reviewed and the indicated failure mode for molding defect was observed, as the shield on the tube was incompletely molded.Additionally, one hundred (100) retention samples from bd inventory were evaluated by visual examination and the issue of a molding defect was not observed.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 has been confirmed for the indicated failure mode of molding defect based on the photos provided; however, retention samples were satisfactory.Bd was not able to identify a root cause for the indicated failure mode.Based on the low defect rate for the batch in question, no actions are planned at this time.
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It was reported when using the bd vacutainer® lh 68 i.U.Plus blood collection tube the cap/lid was broken.The following information was provided by the initial reporter.The customer stated: stage: when unpacking, defect: the shield of the tube is broken, quantity: 1 piece.Effects: no effects on patients or users.
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