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Catalog Number 304622 |
Device Problems
Break (1069); Gas/Air Leak (2946)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/12/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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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Event Description
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It was reported that the needle 18ga 1-1/2in sb tw experienced breakage during use with the needle breaking at the junction of the steel and plastic.The customer stated, "during reconstitution of chemotherapy, the preparator took with the needle into the solute bag.Tapping lightly on the needle, following the appearance of a bubble, the needle broke in two at the junction between steel and plastic.¿.
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Event Description
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It was reported that the needle 18ga 1-1/2in sb tw experienced breakage during use with the needle breaking at the junction of the steel and plastic.The customer stated, "during reconstitution of chemotherapy, the preparator took with the needle into the solute bag.Tapping lightly on the needle, following the appearance of a bubble, the needle broke in two at the junction between steel and plastic.¿.
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Manufacturer Narrative
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Investigation summary: bd has reviewed our production and inspection records and have established that all production and quality processes were carried out normally.Neither qn nor ncmr's.Needles were packed in machine 2103 (october 18-21st, 2018) during which 58 visual inspections were carried out without defects noted.Needles (#8281795) were assembled in machine #4407 on october 16-21st, 2018 during which 250 visual inspections were performed without defects noted related to assembly process.1qn (#10952) was reached related to flashes which would not affect the reported issue.Epoxy batches i682002588 and i682071548.Cannula batches: #8235744 and #8208699.Injected hub batches #8282096, #8271589 and #8267674 (mold machine 3548 from september 24th to october 23rd, 2018 during which 1qn (#11110) was reached related to flashes which would not affect the reported issue).No samples provided.Picture shows a broken hub (pink plastic part) at the level of middle hub.Conclusion(s): a combination of manufacturing issue (may be produced in the tray of the hub feeder where if any hub has some inappropriate placement due to some unexpected movement, it could have been enough damaged) and an incorrect handling which provoke hub breaks itself during handling.Since review dhr showed no indication of the alleged defect, this is the first time this lot is reported for this defect, and taking into account root cause could not be determine, no correction actions are required.
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Search Alerts/Recalls
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