Catalog Number 320584 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A 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.B.3.Date of event: unknown.The date received by manufacturer has been used for this field.D.4.Medical device expiration date: unknown.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.
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Event Description
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It was reported that the bd micro fine ultra¿ pen needles 0,23mm (32g) x 4mm - 100 count eu was broken.The following information was provided by the initial reporter, translated from dutch to english: some of the pen needles are bent and broken so that no insulin comes through the needle.
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Manufacturer Narrative
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H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no capa/sa is required at this time.
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Event Description
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It was reported that the bd micro-fine ultra¿ pen needles 0,23mm (32g) x 4mm - 100 count eu was broken.The following information was provided by the initial reporter, translated from dutch to english: some of the pen needles are bent and broken so that no insulin comes through the needle.
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Search Alerts/Recalls
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