Model Number 367283 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/16/2021 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: 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.
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Event Description
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It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
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Event Description
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It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
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Manufacturer Narrative
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A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Oem manufacture: 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.
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Event Description
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It was reported that bd vacutainer® safety-lok¿ blood collection set was clogged.The following information was provided by the initial reporter: " when drawing the patient, the sample comes into the tubing and stops.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 12/13/2021.H.6.Investigation: bd received 86 samples from the customer for investigation.All samples were evaluated by visual examination and functional testing and the indicated failure mode with the incident lot was not observed.Additionally, 50 retention samples from bd inventory were evaluated by visual examination and functional testing and no issues were observed 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.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Search Alerts/Recalls
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