BARD ACCESS SYSTEMS SAFESTEP HUBER NEEDLE SET 22G X 0.75IN; SET, ADMINISTRATION, INTRAVASCULAR
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Model Number N/A |
Device Problem
Component Missing (2306)
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Patient Problem
No Patient Involvement (2645)
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Event Date 10/08/2019 |
Event Type
malfunction
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Manufacturer Narrative
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The information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of asdss0042 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that when opening the package, it was noticed that the cover of needle was not contained in it and the needle was bent.There was no reported patient involvement.
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Manufacturer Narrative
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The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a missing needle cover was inconclusive due to the condition of the returned sample.The product returned for evaluation was one 22ga x 0.75¿ safestep safety infusion set.The sample was received with its original opened packaging.The sample appeared free of usage residues and the safety mechanism was not engaged.The needle cover was missing from the needle shaft and was not returned for evaluation.While no cover was present on the needle shaft, the opened state of the packaging prevented determination of the original state of the device.Consequently this complaint is inconclusive at this time.A lot history review (lhr) of asdss0042 showed no other similar product complaint(s) from this lot number.
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Event Description
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It was reported that when opening the package, it was noticed that the cover of needle was not contained in it and the needle was bent.There was no reported patient involvement.
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