Model Number 305916 |
Device Problem
Unintended Movement (3026)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
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.The customer's address is unknown: (b)(6), usa has been used as a default. 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 at least 20 bd safetyglide¿ needles experienced difficult plunger movement.The following information was provided by the initial reporter: we have tried at least 20 needles from this box, and they are not plunging correctly.
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Manufacturer Narrative
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H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.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 at least 20 bd safetyglide¿ needles experienced difficult plunger movement.The following information was provided by the initial reporter: we have tried at least 20 needles from this box, and they are not plunging correctly.
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Search Alerts/Recalls
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