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 Codes	Awareness during Anaesthesia (1707); Insufficient Information (4580)
Date of Event	11/04/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Pma/510(k)#: enforcement discretion.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that tray spn whit25g3.5 l/b-d/e blue drape anesthesia was ineffective.This occurred on 8 occasions.The following information was provided by the initial reporter: material no: 405672 batch no: 0001378841.It was reported that: some of the bupivicaine 0.75% from the kits were ineffective.Event description per email states: one of the anesthesia nurses alerted me this morning of a problem with some of the spinal kits.She said that some of the bupivicaine 0.75% is not working on patients and they are now pulling that out of the pyxis, so we are wasting the bupivicaine in the kits.She was unable to retrieve because the anesthesiologists have been throwing the kits into the sharps buckets.She knows of 6 or 8 kits with issues, {in a couple locations}.
Additional Manufacturer Narrative
H.6.Investigation: a review of the device history record noted no issues relating to the reported failure mode for 405672 lot # 0001378841.No complaint sample or photo was provided for evaluation.Although a sample was not provided for evaluation, mannford¿s stability program runs a single lot each year to ensure our processes does not affect the drug potency.Stability program returned acceptable results.Consequently, the investigation was not able to confirm the reported failure mode.Based on the complaint investigation, the failure mode could not be confirmed and as a result a probable root cause could not be identified.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.
Event or Problem Description
It was reported that tray spn whit25g3.5 l/b-d/e blue drape anesthesia was ineffective.This occurred on 8 occasions.The following information was provided by the initial reporter: material no: 405672 batch no: 0001378841.It was reported that: some of the bupivicaine 0.75% from the kits were ineffective.Event description per email states: one of the anesthesia nurses alerted me this morning of a problem with some of the spinal kits.She said that some of the bupivicaine 0.75% is not working on patients and they are now pulling that out of the pyxis, so we are wasting the bupivicaine in the kits.She was unable to retrieve because the anesthesiologists have been throwing the kits into the sharps buckets.She knows of 6 or 8 kits with issues, {in a couple locations}.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10929859
• Report Number: 1625685-2020-00098
• Device Sequence Number: 3186247
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (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): 03/08/2021

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: 12/31/2021
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001378841
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/04/2020
• Supplement Date Received by Manufacturer: 03/08/2021
• Initial Report FDA Received Date: 12/01/2020
• Supplement Report FDA Received Date: 03/15/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/19/2020
• 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