Catalog Number 367283 |
Device Problem
Filling Problem (1233)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2024 |
Event Type
malfunction
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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.There were multiple 510k numbers reported to be involved.The information is as follows: g.5.Pma / 510(k)#: k991088.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 that while using bd vacutainer® safety-lok¿ blood collection set, there was insufficient blood flow.No patient impact reported.The following was provided by the initial reporter: "the wingset isn't gaining suction and wasn't collecting blood".
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Event Description
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It was reported that while using bd vacutainer® safety-lok¿ blood collection set, devices are leaking blood from the np needle when inserted into the vacuette tubes.One box was affected.No patient impact reported.
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Manufacturer Narrative
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The following fields have been updated with additional information.Customer provided clarifying information regarding event details.B5: it was reported that while using bd vacutainer® safety-lok¿ blood collection set, devices are leaking blood from the np needle when inserted into the vacuette tubes.One box was affected.No patient impact reported.D10: device available for evaluation: yes.D10: returned to manufacturer on: 08-mar-2024.H.6.Investigation summary: material #: 367283, lot/batch #: 23d0591.Bd received 5 samples for investigation.The samples were evaluated by visual examination and functional leak testing and the indicated failure mode for leakage with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and another 8 by functional leak 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 issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode leakage.Bd was not able to identify a root cause for the indicated failure mode.
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Search Alerts/Recalls
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