Catalog Number UNKNOWN |
Device Problem
Misconnection (1399)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/03/2022 |
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 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).The date received by manufacturer has been used for this field.Device expiration date: unknown.The customer's address is unknown: (b)(6) has been used as a default. fda notified: the initial reporter notified the fda via uf/importer report#: mw (b)(4).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 an unspecified number of unspecified bd pen needles were not functioning.The following information was provided by the initial reporter: patient reports defective pen needles.
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Event Description
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It was reported that an unspecified number of unspecified bd pen needles were not functioning.The following information was provided by the initial reporter: patient reports defective pen needles.
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Manufacturer Narrative
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H.6.Investigation: 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.
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Search Alerts/Recalls
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