MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE; ANESTHESIA CONDUCTION KIT

Model Number	405672
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape bupivacaine anesthesia was ineffective during use, as the patient "did not get numb at all".The following information was provided by the initial reporter: "placed spinal with no indication of malplacement.There was no effect from bupivacaine.Patient did not get numb at all.We had to place another spinal.".
Additional Manufacturer Narrative
H.6.Investigation summary.A complaint history check was performed, and this is the first related complaint reported with the defect/condition of anesthesia ineffective for the lot.Additionally, a review of the device history record noted no manufacturing issues relating to the reported failure mode.A sample was not provided for evaluation.However, a picture confirming the lot number was provided and retained samples were reviewed and confirmed as visually acceptable.The investigation was not able to identify or confirm any manufacturing contribution to the reported failure mode.All indicators suggest 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.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.Based on the reported failure mode, a supplier quality notification was sent to the vendor to notify them of the reported failure mode (ineffective anesthesia).This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences and captured through the quality data analysis (qda) process if any adverse trend is identified.
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape bupivacaine anesthesia was ineffective during use, as the patient "did not get numb at all".The following information was provided by the initial reporter: "placed spinal with no indication of malplacement.There was no effect from bupivacaine.Patient did not get numb at all.We had to place another spinal.".

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10228575
• Report Number: 1625685-2020-00056
• Device Sequence Number: 536459
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2021
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001351300
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/11/2020
• Supplement Date Received by Manufacturer: 06/11/2020
• Initial Report FDA Received Date: 07/03/2020
• Supplement Report FDA Received Date: 10/01/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/20/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other