Model Number 192-N251S |
Device Problem
Failure to Deliver (2338)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.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.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.B.3.Date of event is unknown; awareness date has been used for this field.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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Event Description
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It was reported while using the bd safetyglide¿ needle the needle was clogged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: we found two more that were defective and switched the vaccine for saline and tried pushing fluid through with as much force as we could and they would not work.
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Manufacturer Narrative
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H6: investigation summary: no samples or photos received by our quality team for evaluation.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Previous investigations have revealed that process variations during the needle lubricant application can create clogged needles.Several quality initiatives have been implemented on manufacturing line to ensure that the needle lubricant application is properly applied during the manufacturing process.Additionally, a monitoring program is also in place to verify the needle lubricant is applied uniformly to the needle.
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Event Description
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It was reported while using the bd safetyglide¿ needle the needle was clogged.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter: we found two more that were defective and switched the vaccine for saline and tried pushing fluid through with as much force as we could and they would not work.
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Search Alerts/Recalls
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