Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.H3 other text : see h10 manufacture narrative.
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Material#: 405671 lot # 0001515975,0001514170,0001523441 it was reported by the customer that we had an anesthesiologist report that he experienced four events where the marcaine was not effective or ¿failed¿ verbatim: rcc received a complaint via email.Email(s) attached.We had an anesthesiologist report that he experienced four events where the marcaine was not effective or ¿failed¿ there were three different lot # of trays identified.Catalog # 405671 lot # 0001515975 lot # 0001514170 lot # 0001523441 we have pulled and quarantined about (b)(4) trays from the hospital shelves and (b)(4) at our warehouse.These are currently in my office.The physician is very concerned and wants to be kept informed as to the results of your investigation.Please coordinate with our team as soon as possible to expedite a resolution to this issue.26jan2024: per follow up from customer: i believe they redid the spinal and it worked then when they used a different vial of marcaine.
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No samples or photos received for investigation.A device history review was performed for lot 0001515975, 0001514170, 0001523441,0001536091 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Retained samples from the same lot were evaluated, no issues or defects observed.The sterilization release record was reviewed for the finished good trays, the requirements for it's release were met.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.Final products in this manufacturing line, for this reference are sampled and they are subjected to visual and functional inspections during the different manufacturing sub-processes according to procedures.Manufacturing personnel have been notified of this incident to increase awareness.
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