Catalog Number UNKNOWN |
Device Problem
Break (1069)
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Patient Problems
Device Embedded In Tissue or Plaque (3165); No Code Available (3191)
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Event Date 09/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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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.(b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
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Event Description
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It was reported that during use of the unspecified bd syringe the tip of the needle broke off in patients leg.Two surgeries were performed to remove the cannulas.The following information was provided by the initial reporter: the needle had been broken twice and had to be surgically removed.
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Manufacturer Narrative
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Investigation: no samples (including photos) were returned as of 18 november 2019 therefore the complaint could not be confirmed and the root cause is undetermined.Cannot perform a dhr review due to unknown lot number.
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Event Description
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It was reported that during use of the unspecified bd¿ syringe the tip of the needle broke off in patients leg.Two surgeries were performed to remove the cannulas.The following information was provided by the initial reporter: the needle had been broken twice and had to be surgically removed.
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Search Alerts/Recalls
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