Catalog Number 367528 |
Device Problems
Crack (1135); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation summary: bd had not received samples, but six (6) photos were provided for investigation.The photos were reviewed and showed that the shrink film on the top of the shelf pack was torn and 3 caps were cracked.Additionally 2 retained shelf packs were visually inspected, and no cracked caps and no torn packaging were found.Bd was able to confirm the customer¿s indicated failure mode of torn packaging and cracked cap from the photos provided.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.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 vacutainer® sst¿ ii advance plus blood collection tube the a broken lid/cap.The following information was provided by the initial reporter.The customer stated: "the customer reported that the film package was found to be torn.I found the top of the package was torn and the top of hemogard cap of 3 tubes had crack.".
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but six (6)photos were provided for investigation.The photos were reviewed and showed that the shrink film on the top of the shelf pack was torn and 3 caps were cracked.Additionally 2 retained shelf packs were visually inspected, and no cracked caps and no torn packaging were found.Bd was able to confirm the customer¿s indicated failure mode of torn packaging and cracked cap from the photos provided.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.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® sst¿ ii advance plus blood collection tube the a broken lid/cap the following information was provided by the initial reporter.The customer stated: "the customer reported that the film package was found to be torn.I found the top of the package was torn and the top of hemogard cap of 3 tubes had crack.".
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Search Alerts/Recalls
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