Catalog Number UNKNOWN |
Device Problem
Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/26/2023 |
Event Type
malfunction
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Event Description
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It was reported that while using the unspecified bd ¿ syringe the plunger falls out of barrel.The following was received by the initial reporter: consumer stated, when she pulls on plunger prior to injection, the plunger falls out of barrel and she is unable to use it.
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Manufacturer Narrative
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B.3.Date of event: unknown.The date received by manufacturer has been used for this field.Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in sections d.3.And g.1.And the franklin lakes fda registration number has been used for the manufacture report number.D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H3.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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Manufacturer Narrative
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H6: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Due to the batch being unknown, no dhr review can be completed.H3 other text : see h10.
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Event Description
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It was reported that while using the unspecified bd ¿ syringe the plunger falls out of barrel.The following was received by the initial reporter: consumer stated, when she pulls on plunger prior to injection, the plunger falls out of barrel and she is unable to use it.
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Search Alerts/Recalls
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