Catalog Number 515064 |
Device Problem
Deflation Problem (1149)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 01/30/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.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 whenever the "drug cyclophosphamide is reconstituted and prepared", the bd phaseal¿ optima protector (p20-o) chamber would expand but not deflate.
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Manufacturer Narrative
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The information was re-evaluated for this complaint and was determined to not be reportable.Expansion chamber does not deflate: when the expansion chamber does not deflate, this may lead to customer dissatisfaction and/or a delay in preparation but it is unlikely to lead to any degree of harm/serious injury.3003152976-2019-00152 is null and void as a result.
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Event Description
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It was reported that whenever the "drug "cyclophosphamide" is reconstituted and prepared", the bd phaseal¿ optima protector (p20-o) chamber would expand but not deflate.
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Manufacturer Narrative
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Investigation summary: one picture was received showing some drops through the hydrophobic filter.No samples are available for investigation.Thirty-one (31) retained samples were taken for investigation.Visual inspection reveals no defects.Twenty (25) samples were inflated through the spike using a syringe with 50 ml of air.All of the samples expanded the chamber properly and no defects were found on the film.Functional test was performed on six (6) samples.The injector was connected to a syringe and attached to the protector + vial, following instructions explained in the ifu.In all cases expansion chamber worked properly (inflated and deflated properly).No leak was found through the hydrophobic filter.Inspections and tests: according to ph-322, visual inspection of protector takes place during manufacturing process.(the correct assembly of the components and the absence of foreign matter are verified).According to ph-322 leak test and burst test are performed on the first lot of each month using a z-axis equipment.The volume of the expansion chamber is checked on the first lot of each month according to ph-322/pc-225 as well.The machine has a leak test and flow test, both tests will detect if the sample has the channels 100% blocked in such a way that he chambers can´t be inflated.Flow test will detect the bad sample since the flow rate will be 0 l/min.Leak test will detect the bad samples since the chamber will not be thermoformed and consequently, the leak test will fail or even will not start.Conclusion(s): no issues found related to the protector (expansion chamber inflates and deflates properly and no leak was found).No issues were found during protector manufacturing process.The root cause of the defect may be related to defective injectors.A situation analysis (sa# mps-19-1349-sa) was initiated for the injector complaints with further details related to the investigation: ¿it was observed that lubrication in the membrane pocket and cannula may have migrated into the cannula and potentially occluded the flow location.The batches that demonstrated difficulty in aspirating were then evaluated for lubrication consistency.Several batches demonstrated similar gel like appearance and have been placed on a global hold.Remaining batches were not placed on global hold because they didn't demonstrate difficulty in aspiration.¿ if protectors were used with defective injectors, occlusion may avoid the properly work of the protector chamber.
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Event Description
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It was reported that whenever the "drug cyclophosamide is reconstituted and prepared", the bd phaseal¿ optima protector (p20-o) chamber would expand but not deflate.
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Search Alerts/Recalls
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