Catalog Number 367257 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/03/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 vacutainer® safety-lok¿ blood collection set there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "there has been an issue with leakage of blood through the distal needle during the sample collection procedure.The tubes are from another brand (greiner) and the sharps are from bd.Sample blood was being collected from female patient laying down (per her request), more or less in the 10th tube it began to leak blood inside the holder.".
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.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 vacutainer® safety-lok¿ blood collection set there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "there has been an issue with leakage of blood through the distal needle during the sample collection procedure.The tubes are from another brand (greiner) and the sharps are from bd.Sample blood was being collected from female patient laying down (per her request), more or less in the 10th tube it began to leak blood inside the holder.".
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was blood splatter/leakage or other sample leakage from the device other than the insertion site or needle tip.The following information was provided by the initial reporter.The customer stated: "there has been an issue with leakage of blood through the distal needle during the sample collection procedure.The tubes are from another brand (greiner) and the sharps are from bd.Sample blood was being collected from female patient laying down (per her request), more or less in the 10th tube it began to leak blood inside the holder.".
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Manufacturer Narrative
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H6: investigation summary: bd had not received samples, but 1 photo was provided by the customer for investigation.The photo was reviewed and the indicated failure mode for leakage with the incident lot was observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed relating to leakage 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 non-conformances during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode leakage.Since the number of punctured blood tubes is large, it was conceivable that the reported event was caused because the silicone was scraped off.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h10.
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Search Alerts/Recalls
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