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	Awareness during Anaesthesia (1707)
Date of Event	08/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Oem manufacture: (b)(4).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 experienced ineffective anesthesia, failing to work during use.The following information was provided by the initial reporter: material no.405672 batch no.0001283016, two patients on (b)(6) 2020, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.
Event or Problem Description
It was reported that the tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia, failing to work during use.The following information was provided by the initial reporter: material no.405672 batch no.0001283016.Two patients on (b)(6) 2020, received pre-procedure spinal anesthesia which was ineffective and another type of anesthesia had to utilized by the medical provider.
Additional Manufacturer Narrative
H6: investigation summary: a review of the device history record noted no issues relating to the reported failure mode for 405672, lot # 0001283016.No complaint sample or photo was provided for evaluation.Although a sample was not provided for evaluation, the plant stability program runs a single lot each year to ensure their processes does not affect the drug potency.The stability program returned acceptable results.Consequently, the investigation was not able to confirm the reported failure mode.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.All indicators suggest product 405672, lot # 0001283016, contained a drug with acceptable potency.In addition, the stability program tests one sample of bupivacaine on a yearly basis.The bupivacaine potency result met acceptance criteria and the assay results were all within the specification range of 6.98-8.03 mg/ml.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.H3 other text : see h10.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10709388
• Report Number: 2243072-2020-01690
• Device Sequence Number: 1191656
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 02/23/2021

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: Other
• Device Expiration Date: 04/30/2021
• Device Model Number: 405672
• Device Catalogue Number: 405672
• Device Lot Number: 0001283016
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/28/2020
• Supplement Date Received by Manufacturer: 02/19/2021
• Initial Report FDA Received Date: 10/21/2020
• Supplement Report FDA Received Date: 02/24/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/23/2019
• 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
• Patient Age: 29 YR