Model Number 309581 |
Device Problems
Leak/Splash (1354); Defective Component (2292)
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Patient Problems
Hemorrhage/Bleeding (1888); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/04/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd luer-lok¿ syringe with attached needle the plunger rod was difficult to move and the syringe leaked.There was no report of patient impact.The following information was provided by the initial reporter: material no.309581 batch no.9296333.Consumer reported needles dull.Bleeding at the injection site during injection.Plunger rod difficult to move.Medication leaking (b-12) from syringe, around the needle hub.Consumer stated that she tightens the needle onto the syringe before using.She stated that she does it to make sure that the needle does not loosen while injecting.
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.
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Manufacturer Narrative
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Date of event is unknown; awareness date has been used for this field.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.Unused physical samples from the complaint batch are needed to confirm the noted defects.Please also make sure that needles are not overtightened onto the syringe when hand-tightening.Overtightening can potentially lead to leakage.
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Event Description
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It was reported while using bd luer-lok¿ syringe with attached needle the plunger rod was difficult to move and the syringe leaked.There was no report of patient impact.The following information was provided by the initial reporter: material no.309581 batch no.9296333.Consumer reported needles dull.Bleeding at the injection site during injection.Plunger rod difficult to move.Medication leaking (b-12) from syringe, around the needle hub.Consumer stated that she tightens the needle onto the syringe before using.She stated that she does it to make sure that the needle does not loosen while injecting.
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Search Alerts/Recalls
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