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

Model Number	405673
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medical device expiration date: unknown.The customer's address is unknown.(b)(6) has been used as a default.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.Device manufacture date: unknown.
Event or Problem Description
It was reported that tray spn whit25g3.5 l/b-d/e were not working.The following information was provided by the initial reporter: material no.: 405673, back no.: unknown (1387545 or 1370473).It was reported that the anesthesia in the trays are not working.Per email: ordered a case of spinal trays and the crna is telling me that a few trays of that case were defected.She said they are having to convert to general anesthesia b/c the medication in these kits were not working.
Additional Manufacturer Narrative
Investigation summary: no samples that display the reported condition were available for investigation.A review of the internal manufacturing device records and for the reported lot numbers was performed and no recorded quality problems or rejections related to the reported incident were found.The component involved is provided by a supplier whom we have notified of this incident initiated an investigation request.While we did not have a physical sample, we routinely perform evaluations to ensure our manufacturing process does not impact the potency of the drug provided within the kit, results were reviewed and all results were found to be acceptable.Complaints received for this device and reported condition will continue to be tracked and trended for future occurrence.
Event or Problem Description
It was reported that tray spn whit25g3.5 l/b-d/e were not working.The following information was provided by the initial reporter: material no.: 405673 back.No.: unknown (1387545 or 1370473).It was reported that the anesthesia in the trays are not working.Per email: ordered a case of spinal trays and the crna is telling me that a few trays of that case were defected.She said they are having to convert to general anesthesia b/c the medication in these kits were not working.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 11565987
• Report Number: 2243072-2021-00862
• Device Sequence Number: 11982289
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 00382904056735
• 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): 08/24/2021

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 Model Number: 405673
• Device Catalogue Number: 405673
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/26/2021
• Supplement Date Received by Manufacturer: 08/23/2021
• Initial Report FDA Received Date: 03/24/2021
• Supplement Report FDA Received Date: 08/27/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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