Catalog Number UNKNOWN |
Device Problems
Break (1069); Detachment of Device or Device Component (2907)
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Patient Problem
Device Embedded In Tissue or Plaque (3165)
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Event Date 04/11/2019 |
Event Type
Injury
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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 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 (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that the needle tip of the unspecified bd¿ syringe with needle broke off inside the patient and made the medication dose unusable.The patient reportedly went to urgent care, but no other details were provided.The following information was provided by the initial reporter: a report was received on (b)(6) 2019 via ds.Pharmacist reported that a patient reported that the tip of needle broke off - early (b)(6) - dose unusable.Had to next dose - she did not call in - went to urgent care.No other details provided".
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Event Description
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It was reported that the needle tip of the unspecified bd¿ syringe with needle broke off inside the patient and made the medication dose unusable.The patient reportedly went to urgent care, but no other details were provided.The following information was provided by the initial reporter: a report was received on 15 mar 2019 via ds.Pharmacist reported that a patient reported that the tip of needle broke off - early march - dose unusable.Had to next dose - she did not call in - went to urgent care.No other details provided.".
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Manufacturer Narrative
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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 review could not be completed as no batch number was provided.Based on no sample, the investigation concluded, bd was not able to verify the indicated failure.
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Search Alerts/Recalls
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