MAUDE Adverse Event Report: TRAY SPN SPT24G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405637
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Awareness during Anaesthesia (1707)
Date of Event	06/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Suspect product name and strength: bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine).Pma/510k number: enforcement discretion.
Event or Problem Description
It was reported that tray spn spt24g3.5 l/b-d/e failed to work.The following information was provided by the initial reporter: "it was reported that the marcaine in the spinal tray is compromised.Event description per attached email states: there is concern that these lots have issues with the marcaine that is supplied in the trays.There have been a few reports.Pt scheduled for c/section this am was positioned for a spinal in or.Dr.Administered spinal anesthesia without difficulty, was confident in placement.Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident.Dr.Was concerned that this is the second such case in 36 hours.He had the same incident on a patient on 6/14 at 2100.Again, dr.Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia.Dr.Is concerned that the marcaine in the spinal trays is compromised.".
Event or Problem Description
It was reported that tray spn spt24g3.5 l/b-d/e failed to work.The following information was provided by the initial reporter: "it was reported that the marcaine in the spinal tray is compromised.Event description per attached email states: there is concern that these lots have issues with the marcaine that is supplied in the trays.There have been a few reports.Pt scheduled for c/section this am was positioned for a spinal in or.Dr.Administered spinal anesthesia without difficulty, was confident in placement.Patient did not receive adequate anesthesia to proceed with c/section, case was converted to general anesthesia and proceeded without incident.Dr.Was concerned that this is the second such case in 36 hours.He had the same incident on a patient on 6/14 at 2100.Again, dr.Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia.Dr.Is concerned that the marcaine in the spinal trays is compromised.".
Additional Manufacturer Narrative
The suspect product listed in the c tab was reported erroneously.There was no reportable adverse drug event and therefore the c tab should be disregarded.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2020-08-07.Investigation summary a review of the device history record noted no issues relating to the reported failure mode for 405637 lot # 0001348196.Three unopened trays samples of 405637 / 0001348196 - bupivacaine hcl (0.75%) were received.The fluid color and overall appearance did appear acceptable.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.Per an inspection of the retain samples for this vendor lot, the color and overall appearance are acceptable for drug part #8301694 with raw material lot #10003088822.All indicators suggest product 405637 lot # 0001348196 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.All indicators suggest product 405637 contained a drug with acceptable potency.In addition, mannford¿s stability program runs a single lot each year to ensure our processes does not affect the product.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 spt24g3.5 l/b-d/e failed to work.The following information was provided by the initial reporter: "it was reported that the marcaine in the spinal tray is compromised.Event description per attached email states: there is concern that these lots have issues with the marcaine that is supplied in the trays.There have been a few reports.Pt scheduled for c-section this am was positioned for a spinal in or.Dr.Administered spinal anesthesia without difficulty, was confident in placement.Patient did not receive adequate anesthesia to proceed with c-section, case was converted to general anesthesia and proceeded without incident.Dr.Was concerned that this is the second such case in 36 hours.He had the same incident on a patient on (b)(6) at 2100.Again, dr.Was confident the placement was appropriate, but patient did not receive adequate anesthesia for the procedure and required general anesthesia.Dr.Is concerned that the marcaine in the spinal trays is compromised.".

• Brand Name: TRAY SPN SPT24G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10477828
• Report Number: 2243072-2020-01325
• Device Sequence Number: 3120197
• Product Code: CAZ
• UDI-Device Identifier: 00382904056377
• UDI-Public: 00382904056377
• Combination Product (Y/N): Y
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H.10.
• 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,Followup
• Report Date (Section B): 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 09/30/2021
• Device Model Number: 405637
• Device Catalogue Number: 405637
• Device Lot Number: 0001348196
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/07/2020
• Initial Date Received by Manufacturer: 08/06/2020
• Supplement Date Received by Manufacturer: 08/06/2020; 02/05/2021
• Initial Report FDA Received Date: 09/01/2020
• Supplement Report FDA Received Date: 10/08/2020; 02/12/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/05/2020
• 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