Model Number 405671 |
Device Problem
Patient-Device Incompatibility (2682)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/22/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that the marcaine anesthesia in the bd¿ whitacre spinal tray was ineffective during use.The following information was provided by the initial reporter: "i was recently notified that the drugs in some of our bd spinal kits have not been as effective as hoped.Anecdotally, this same issue happened last summer.There is some concern that the heat could be affecting the items.Can you tell me how the below kit is being stored." "i know of 4 times in a one week period.After that we started not using the marcaine in the kits.I don¿t know the exact week, but i am thinking the first full week in july.We had one adverse event from a patient with a spinal headache.She had to have 2 spinals as the first one was the bad marcaine".
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Event Description
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It was reported that the marcaine anesthesia in the bd¿ whitacre spinal tray was ineffective during use.The following information was provided by the initial reporter: "i was recently notified that the drugs in some of our bd spinal kits have not been as effective as hoped.Anecdotally, this same issue happened last summer.There is some concern that the heat could be affecting the items.Can you tell me how the below kit is being stored." "i know of 4 times in a one week period.After that we started not using the marcaine in the kits.I don¿t know the exact week, but i am thinking the first full week in july.We had one adverse event from a patient with a spinal headache.She had to have 2 spinals as the first one was the bad marcaine.".
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Manufacturer Narrative
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H6: investigation summary no sample was returned for analysis.Consequently, the investigation was not able to further evaluate the reported failure mode through a complaint sample analysis.A device history review could not be completed as no batch number was provided.The investigation was not able to identify or confirm any manufacturing contribution to the reported failure mode.All indicators suggest that the product contained a drug with acceptable potency.Previous corrective actions have already been implemented for ineffective anesthesia.In addition, the manufacturing stability program runs a single lot each year to ensure internal processes does not affect the product.Please refer to the products instructions for use (ifu) provided for proper storage and handling, and any other user requirements.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any further corrective actions for this complaint.H3 other text: see h.10.
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Search Alerts/Recalls
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