MAUDE Adverse Event Report: TRAY SPN WHIT27G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Catalog Number	405699
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001316092, medical device expiration date: 2021-05-31, device manufacture date: 2019-08-15.Medical device lot #: 0001318294, medical device expiration date: 2021-05-31, device manufacture date: 2019-09-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that failed spinal blocks occurred with a tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial reporter, "anesthesia department experienced 3 failed or partial spinal blocks in a 16 hour period with the bupivacaine in the tray.Crna's will continue using our tray but will pull anesthetic from pharmacy.".
Event or Problem Description
It was reported that failed spinal blocks occurred with a tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial reporter, "anesthesia department experienced 3 failed or partial spinal blocks in a 16 hour period with the bupivacaine in the tray.Crna's will continue using our tray but will pull anesthetic from pharmacy.".
Additional Manufacturer Narrative
H.6.Investigation: a dhr review of all applicable manufacturing records for the lot did not identify any issues that may have contributed to the reported failure.A sample was returned for evaluation.The liquid was clear with no noticeable imperfections.The ampule was in good condition.The failure mode could not be confirmed through sample analysis.Each vial was visually inspected for obvious defect.No obvious defects were observed.Liquid within each vial was clear with no noticeable imperfections.All indicators suggest product 405699 for lots 0001316092 and 0001318294 contained a drug with acceptable potency.In addition, the manufacturing stability program runs a single lot each year to ensure any additional processes do not affect the product.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 h.10.

• Brand Name: TRAY SPN WHIT27G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9930502
• Report Number: 1625685-2020-00038
• Device Sequence Number: 19558363
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 382904056995
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 08/20/2020

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: 05/31/2021
• Device Catalogue Number: 405699
• Device Lot Number: SEE. H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/24/2020
• Initial Date Received by Manufacturer: 03/17/2020
• Supplement Date Received by Manufacturer: 03/17/2020
• Initial Report FDA Received Date: 04/06/2020
• Supplement Report FDA Received Date: 08/20/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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