Catalog Number 320559 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2022 |
Event Type
malfunction
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Event Description
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It was reported that the bd micro-fine¿+ pro pen needle leakage.The following information was provided by the initial reporter, translated from japanese to english: and leakage also occurred (the leakage site is unknown).
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Manufacturer Narrative
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H6: investigation summary three sealed 32g x 4 mm pen needle samples and two photos were returned from lot.No.2082863, cat.No.320559.A clog test and a functionality test was carried out on all three samples and no issues were observed.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.No issues were observed with the returned samples therefore no root cause can be identified.
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Event Description
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It was reported that the bd micro-fine¿+ pro pen needle leakage.The following information was provided by the initial reporter, translated from japanese to english: and leakage also occurred (the leakage site is unknown).
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Search Alerts/Recalls
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