Model Number 367281 |
Device Problem
Physical Resistance/Sticking (4012)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 11/15/2022 |
Event Type
Injury
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Manufacturer Narrative
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Oem manufacturer: the manufacturing location for this product is nipro.This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and the franklin lakes fda registration number has been used for the manufacture report number.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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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was difficult to activate safety feature and a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "the safety lock is sticking causing the needle to bend when engaged.Due to the bend the safety does not engage and begins to slide off.Green ¿wings¿ are grasped together and held during blood draw with the bevel up.After withdrawing needle from patient, 2nd hand must be used to steady yellow section and then retract needle by pulling backwards on green wings with 1st hand.Requires significant pressure to pull back and engage safety, causing the needle to bend backwards toward the hand that is holding the green wings.Safety then does not lock into place and needle can be slid back out.The needle bent backwards towards caregiver¿s hand and scratched the top of their finger, drawing blood.The caregiver had to undergo post exposure testing.".
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Manufacturer Narrative
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H.6.Investigation summary: bd received 1 sample for investigation.The sample was 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 relating to safety shield activation 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.Bd was not able to identify a root cause for the indicated failure mode.From the reproduction test, the event was surmised to have happened due to not following the correct procedures for the safety shield activation.As stated in the ifu, please hold the end of the safety shield and the tubing and slide the safety shield straight to cover the winged needle without holding wings.H3 other text : see h.10.
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Event Description
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It was reported when using the bd vacutainer® safety-lok¿ blood collection set there was difficult to activate safety feature and a needle stick injury - post use.The following information was provided by the initial reporter.The customer stated: "the safety lock is sticking causing the needle to bend when engaged.Due to the bend the safety does not engage and begins to slide off.Green ¿wings¿ are grasped together and held during blood draw with the bevel up.After withdrawing needle from patient, 2nd hand must be used to steady yellow section and then retract needle by pulling backwards on green wings with 1st hand.Requires significant pressure to pull back and engage safety, causing the needle to bend backwards toward the hand that is holding the green wings.Safety then does not lock into place and needle can be slid back out.The needle bent backwards towards caregiver¿s hand and scratched the top of their finger, drawing blood.The caregiver had to undergo post exposure testing.".
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Search Alerts/Recalls
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