Catalog Number 320559 |
Device Problem
Defective Device (2588)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/14/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 that pen ndl 32g 4mm pro 14 bag 700 case jpx outer cover would not detach.This was discovered before use.The following information was provided by the initial reporter: the 2 shields were too hard to come off.
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Event Description
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It was reported that pen ndl 32g 4mm pro (b)(4) bag (b)(4) case jpx outer cover would not detach.This was discovered before use.The following information was provided by the initial reporter: the (b)(4) shields were too hard to come off.
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Manufacturer Narrative
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H.6.Investigation summary two open 32g x 4mm pen needle samples and four photos were returned from lot.No.9015918, cat.No.320559.Visual examination of the returned sample and photos was carried out and a broken non patient end of cannula was observed on both samples.Investigation conclusion visual examination of the returned sample and photos was carried out and a broken non patient end of cannula was observed on both samples.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 per the applicable operations and met qc specifications.Root cause description as the samples returned were open it is not possible to confirm this defect to be manufacturing related.Rationale based on an evaluation of severity and occurrence it was determined that no corrective action is required at this time.H3 other text : see section h.10.
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Search Alerts/Recalls
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