Catalog Number 367256 |
Device Problem
Component Misassembled (4004)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/13/2022 |
Event Type
malfunction
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set the device disconnects and blood leaked.The following information was provided by the initial reporter.The customer stated: verbatim: when changing tubes, the device disconnects and blood leaks.There were several reports regarding the issue.
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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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 2c14a1.Medical device expiration date: 2025-03-31.Device manufacture date: 2022-07-07.Medical device lot #: 2a16a1.Medical device expiration date: 2025-01-31, device manufacture date: 2002-04-20.Medical device lot #: 2c13a1.Medical device expiration date: 2025-03-31.Device manufacture date: 2022-07-07.Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(6), nj has been listed and the (b)(6) fda registration number has been used for the manufacture report number.
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Manufacturer Narrative
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H.6.Investigation summary: bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to separates during use as all samples met specifications.Based on a review of the device history record for the incident lots, 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.Bd was not able to identify a root cause for the indicated failure mode.Regarding the factors at the time of use, it was surmised that the luer adapter loosened and disconnected due to some external force applied while connecting the luer adapter with the holder or during blood draw.As stated in the ifu, ¿check to ensure that the female luer adapter (a) is securely attached to the male luer adapter (b) and that the male luer adapter (b) is securely attached on the holder.¿ please be careful when using the product.
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set the device disconnects and blood leaked.The following information was provided by the initial reporter.The customer stated: verbatim: when changing tubes, the device disconnects and blood leaks.There were several reports regarding the issue.
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Search Alerts/Recalls
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