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 12/13/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 non-patient end of 7 bd micro-fine¿+ pro pen needles were broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from japanese: "when checking the product, i saw the needle npe broken.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval: yes.D10: returned to manufacturer on: 10-jan-2023.H6: investigation summary: wo open 32g x 4mm pen needle samples and three photos were returned from an unknown lot.No., cat.No.320559.Visual examination was carried out on the returned samples and photos and a bent non patient end of cannula was observed on one sample due to the condition this sample was returned no clog test could be carried out.A clog test was carried out on the remaining sample and no issues were observed.No dhr review can be carried out as lot number is unknown.As the samples returned were open it is not possible to confirm this defect to be manufacturing related.
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Event Description
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It was reported that the non-patient end of 7 bd micro-fine¿+ pro pen needles were broken.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from japanese: "when checking the product, i saw the needle npe broken.".
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Search Alerts/Recalls
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