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

Catalog Number 405699

Device Problem Patient-Device Incompatibility (2682)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/17/2020

Event Type  malfunction  

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 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 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.".

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
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9930502
• MDR Text Key: 202233213
• Report Number: 1625685-2020-00038
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 382904056995
• Combination Product (y/n): N
• PMA/PMN Number: DISCRETION
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Date Manufacturer Received: 03/17/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other