Model Number 309657 |
Device Problems
Break (1069); Material Too Soft/Flexible (4007)
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Patient Problem
Needle Stick/Puncture (2462)
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Event Date 10/26/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.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 luer-lok¿ tip disposable syringes' plungers bent easily during use, and some broke.The following information was provided by the initial reporter: "she mentioned that the plunger bends and sometimes snaps.".
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Manufacturer Narrative
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H.6.Investigation: one box containing one-hundred and eighty-nine 3ml syringes (p/n 309657) sealed in blisterpaks from batch #1181532 were received.The samples were visually evaluated.No visual defects were observed.It should be noted that there was no plunger rod abnormalities present that would lead to the complaint defect.It is unclear in what way the syringe was being used that may have led to the plunger rod snapping as the customer reported.Since the samples did not display the reported condition a potential root cause could not be defined and corrective actions are not necessary.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.
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Event Description
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It was reported that 3 bd luer-lok¿ tip disposable syringes' plungers bent easily during use, and some broke.The following information was provided by the initial reporter: "she mentioned that the plunger bends and sometimes snaps.".
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Search Alerts/Recalls
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