Catalog Number 367285 |
Device Problem
Difficult or Delayed Activation (2577)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 09/26/2023 |
Event Type
Injury
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Manufacturer Narrative
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The manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1., and the franklin lakes fda registration number has been used for the manufacture report number.G.5: pma / 510(k)#k980414 , k991088.H.3.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 that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hic, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 1 of 4.
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Event Description
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It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hiv, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 1 of 4.
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Manufacturer Narrative
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The following field was updated with corrected information: b.3.Date of event: (b)(6) 2023.
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Event Description
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It was reported that while using the bd vacutainer® safety-lok¿ blood collection set that the safety shield is hard to activate causing 4 needlesticks.Each affected nurse had to have hic, hep c and hep b tests performed.At least 2 staff had to have further medical intervention.Report 1 of 4.
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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for evaluation: yes.D.9:device eval by manufacturer? yes.D9: returned to manufacturer on: 21-mar-2024.H.6 investigation summary: material #: 367285.Lot/batch #: 23d2211.Bd received 3 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure mode for difficult to activate safety shield with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and another 8 retention samples by functional testing and no issues were observed relating to difficult to activate safety shield 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 difficult to activate safety shield.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.H3 other text : see h.10.
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Search Alerts/Recalls
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