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 05/29/2023 |
Event Type
Injury
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Event Description
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It was reported while using bd vacutainer® safety-lok¿ blood collection set, the safety shield is hard to activate and caused a needlestick injury to the health care worker.Post exposure protocol was followed.Further information about detailed medical care was not provided.No patient impact reported.
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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.D4.Medical device lot#: unknown.D4.Medical device expiration date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Manufacturer Narrative
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H.6 investigation summary: material #: 367285.Lot/batch #: unknown.Bd had not received samples, but 1 photo was provided for investigation.The photo was reviewed and the indicated failure mode for difficult to activate the safety shield was not observed.In addition, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.Complaints received for this device and reported condition will continue to be tracked and trended.
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Event Description
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It was reported while using bd vacutainer® safety-lok¿ blood collection set, the safety shield is hard to activate and caused a needlestick injury to the health care worker.Post exposure protocol was followed.Further information about detailed medical care was not provided.No patient impact reported.
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Search Alerts/Recalls
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