Catalog Number 329460 |
Device Problem
Device Difficult to Setup or Prepare (1487)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 06/07/2018 |
Event Type
Injury
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Manufacturer Narrative
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Date of event: unknown.(b)(6).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 that the bd safety-lok" insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
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Manufacturer Narrative
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Correction from expiration date 09/30/2018 to expiration date: 09/30/2019.
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Event Description
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It was reported that the bd safety-lok¿ insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
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Manufacturer Narrative
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Investigation summary: customer returned 1cc 13mm 29g syringes and two open blister packs with lot #4176651.Customer states safety mechanism is not being activated.The returned syringes were examined and both exhibited the hub-needle/shield assembly separated from the barrel.Capa # (b)(4) has been opened to address this issue.A review of the device history record was completed for batch #4176651.All inspections were performed per the applicable operations qc specifications.There were two notifications [200570419, 200561806] noted that did not pertain to the complaint.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure ¿ hub separation.Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure - needle stick.Investigation conclusion: possible root causes for hub separates: increase jams from the worn or incorrect swing fingers causing double load on the hub loader putting extra stress on the hubs causing cracking.Raised hub detection is only challenged once a week which limits the ability to detect this defect in a timely manner.Capa # (b)(4) has been opened to address this issue.
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Manufacturer Narrative
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Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: device returned to manufacture: yes.
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Event Description
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It was reported that the bd safety-lok¿ insulin syringe was difficult to operate and the safety mechanism is not being activated.Nurse technician had a needle stick injury.Due the needle stick there was contact with the patient blood and the professional.Rapid test performed in the patient and the professional.Found during use.
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Search Alerts/Recalls
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