Model Number 21-2767-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Needle Stick/Puncture (2462); Reaction to Medicinal Component of Device (4574)
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Event Date 08/01/2022 |
Event Type
Injury
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that a loss of drugs were detected in three (3) patients with standard home chemotherapy infusions.Patients presented a puncture area with a crystallized appearance around the device, and one of the patients presented a skin lesion at the reservoir site.Local and oral antibiotic prescriptions were required.Additional information was requested; however, no further information was received.
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Manufacturer Narrative
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Other text: a product sample was received and is awaiting evaluation and investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Manufacturer Narrative
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H10: a device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.Two product samples were received for evaluation.Visual and functional testing was performed.Visual inspection found the safety mechanism activated; damage cannot be observed on the base and needle.Functional testing performed by introducing water with a syringe.Occlusion and leakage were not observed.Device passed all functional testing.No problem found.Root cause cannot be determined as the sample was successfully tested and no discrepancies were detected.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken accordingly.This remediation mdr was generated under protocol b10010579, as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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