Model Number 305916 |
Device Problems
Obstruction of Flow (2423); Defective Device (2588)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/29/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 3 bd safetyglide¿ needles were clogged.The following information was provided by the initial reporter: we have detected faulty bd safety glide injection needles.Needle does not allow to push fluid through it.Having to inject a client more than once to change out the needle, causing increased time, pain and higher likelyhood of needle stick injury we have identified another lot# that is providing the same defect.Both defected lot #s share the same ref and exp.I have kept a needle from the discovering of this new lot today to provide you with an example.I am available anytime today to chat, i have started the product complaint form attached.25gx1ref 305916lot 2024137exp 2026-12-31 i wasn¿t sure if this would be a cardinal health issue or whether we would forward this straight to bd, please inform if there is something i should be doing differentlysamples of the defective product are available.I have also included attached notes.Please provide a return goods authorization#, your courier account number and any instructions for return shipment.Please indicate whether hsn will receive credit and/or replacement product for the damaged/defective goods.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 09-jan-2023.H6: investigation summary: it was reported the needle would not push fluid through it.To aid in the investigation, one sample with no packaging blister was received for evaluation by our quality team.A visual inspection was performed and no defects or imperfections were observed.The sample was then connected to a syringe with saline solution.The sample did not expel the solution; this needle is clogged.A device history record review was completed for provided material number 305916, lot number 2010821.The review revealed all visual inspections were performed as per requirement with no quality notifications related to the complaint defect.Batch 2010821 was inspected and accepted based on meeting our inspection control plan and subsequently approved for shipment.Based on the investigation with the returned sample analysis the symptom reported by the customer is confirmed.
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Event Description
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It was reported that 3 bd safetyglide¿ needles were clogged.The following information was provided by the initial reporter: we have detected faulty bd safety glide injection needles.Needle does not allow to push fluid through it.Having to inject a client more than once to change out the needle, causing increased time, pain and higher likelyhood of needle stick injury we have identified another lot# that is providing the same defect.Both defected lot #s share the same ref and exp.I have kept a needle from the discovering of this new lot today to provide you with an example.I am available anytime today to chat, i have started the product complaint form attached.25gx1ref 305916lot 2024137exp 2026-12-31 i wasn¿t sure if this would be a cardinal health issue or whether we would forward this straight to bd, please inform if there is something i should be doing differentlysamples of the defective product are available.I have also included attached notes.Please provide a return goods authorization#, your courier account number and any instructions for return shipment.Please indicate whether hsn will receive credit and/or replacement product for the damaged/defective goods.
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Search Alerts/Recalls
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