Catalog Number 367324 |
Device Problems
Difficult or Delayed Activation (2577); Physical Resistance/Sticking (4012)
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Patient Problems
Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/11/2022 |
Event Type
Injury
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set, the user experienced a needlestick injury, post use while trying to activate the safety feature.This event occurred once.Medical intervention, post procedural protocol occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the safety shield did not retract properly thus resulting in a needle stick injury.Did exposure to blood occur? yes, the needle that caused the needlestick had already been used on a patient.If it did, was there any post exposure testing or medical intervention? yes, we followed our ¿needlestick¿ protocol for patient and source testing.Customer concern: one of our staff members had a needle stick today because she pushed the button on the butterfly needle for retraction, heard a snap, but didn't realize the needle didn't disappear and stuck her finger.This happened today (b)(6) 2022) at 8:20 am.She was using a vacutainer holder and drew 2 tubes.No redraw was necessary.
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Manufacturer Narrative
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There were multiple medical device types reported to be involved.The information for the additional device type is as follows: medical device type: fpa.Common device name: intravascular administration set.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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Manufacturer Narrative
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The following fields were updated due to additional information: d9: device available for evaluation: yes.D9: returned to manufacturer on: 2022-10-20.H.6.Investigation summary: bd received 10 samples for investigation.The samples were evaluated by visual examination and functional testing and the indicated failure mode for retraction failure with the incident lot was not observed as all product specifications were met.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 retraction failure.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® push button blood collection set, the user experienced a needlestick injury, - post use while trying to activate the safety feature.This event occurred once.Medical intervention, -post procedural protocol occurred.The following information was provided by the initial reporter.The customer stated: it was reported by the customer that the safety shield did not retract properly thus resulting in a needle stick injury.Did exposure to blood occur? yes, the needle that caused the needlestick had already been used on a patient.If it did, was there any post exposure testing or medical intervention? yes, we followed our ¿needlestick¿ protocol for patient and source testing.Customer concern: one of our staff members had a needle stick today because she pushed the button on the butterfly needle for retraction, heard a snap, but didn't realize the needle didn't disappear and stuck her finger.This happened today ((b)(6) 2022) at 8:20 am.She was using a vacutainer holder and drew 2 tubes.No redraw was necessary.
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Search Alerts/Recalls
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