Catalog Number 320559 |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/05/2022 |
Event Type
malfunction
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Event Description
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It was reported while using bd micro-fine¿ pro pen needles 32g x 4mm (70 count) the cannula broke.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle pe was found to be bent in some products and the needle pe was also found to be broken in some products.
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd micro-fine¿ pro pen needles 32g x 4mm (70 count) the cannula broke.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from japanese to english: the customer reported that the needle pe was found to be bent in some products and the needle pe was also found to be broken in some products.
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Manufacturer Narrative
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H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A device history review could not be completed as no batch number was provided.H3 other text : see h10.
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Search Alerts/Recalls
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