Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/02/2024 |
Event Type
malfunction
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Event Description
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It was reported that the unspecified bd¿ pen needle cannula broke off.The following information was provided by the initial reporter: rear cannula end is broken.
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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 catalog and/or 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.H.3.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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The following fields were updated due to additional information: d9: device available for eval yes.D9: returned to manufacturer on: 28-feb-2024.H.6.Investigation summary: samples were received and an investigation was performed.Embecta was able to duplicate or confirm the indicated issue.Complaints received for this device and reported condition will continue to be tracked and trended.Based on the above, no additional investigation and corrective/preventative action (capa) or situational analysis (sa) is required.
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Event Description
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It was reported that the unspecified bd¿ pen needle cannula broke off.The following information was provided by the initial reporter: rear cannula end is broken.
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Search Alerts/Recalls
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