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	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter occupation: demand planner, logistics supply chain operations.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0001346903.Medical device expiration date: 2021-10-31.Device manufacture date: 2020-02-28.Medical device lot #: 0001346885.Medical device expiration date: 2021-10-31.Device manufacture date: 2020-02-28.Pma/510(k)#: enforcement discretion.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 an unspecified number of tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -failed to work.Product defect occurred during use.The following information was provided by the initial reporter: material no: 405672 ; batch no: 0001346903 , 0001346885.I have just been informed from one of our facilities that the bupivacaine in our bd anesthesia tray (part number 405672) does not work for numbing a patient.They tried 2 trays and neither worked.The lot numbers are 0001346903 (0 kits in the isc, but we will be receiving some back from the facility) and 001346885 (currently 104 kits on hand in the isc).
Additional Manufacturer Narrative
H6: investigation summary a review of the device history record noted no manufacturing issues relating to the reported failure mode for 405672, lot #¿s 0001346903 and 0001346885.Two samples of bupivacaine hcl (0.75%) were received.The fluid color and overall appearance did appear acceptable.The failure mode could not be confirmed.Although the sample was provided, it did not allow for precise evaluation.The investigation was also not able to identify or confirm any contribution to the reported complaint failure.Per inspection of retained samples for this vendor lot, the color and overall appearance are acceptable for drug part #8301694 with raw material lot #10003088823.All indicators suggest product 405672 lot #¿s 0001346803 and 0001346885 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.All indicators suggest product 405672 contained a drug with acceptable potency.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any further corrective actions for this complaint.Based on the reported failure mode, a supplier notification was sent to the vendor to notify them of the reported failure mode (ineffective anesthesia).This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences and captured through the quality data analysis (qda) process if any adverse trend is identified.Capa 67717 exists for this complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of tray spn whit25g3.5 l/b-d/e blue drape experienced ineffective anesthesia -failed to work.Product defect occurred during use.The following information was provided by the initial reporter: material no: 405672, batch no: 0001346903 , 0001346885.I have just been informed from one of our facilities that the bupivacaine in our bd anesthesia tray (part number 405672) does not work for numbing a patient.They tried 2 trays and neither worked.The lot numbers are 0001346903 (0 kits in the isc, but we will be receiving some back from the facility) and 001346885 (currently 104 kits on hand in the isc).

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E BLUE DRAPE
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10377102
• Report Number: 1625685-2020-00071
• Device Sequence Number: 16746015
• Product Code: CAZ
• UDI-Device Identifier: 00382904056728
• UDI-Public: 00382904056728
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: SEE H10
• 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): 12/07/2020

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: 405672
• Device Catalogue Number: 405672
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/06/2020
• Initial Date Received by Manufacturer: 07/17/2020
• Supplement Date Received by Manufacturer: 12/04/2020
• Initial Report FDA Received Date: 08/06/2020
• Supplement Report FDA Received Date: 12/08/2020
• 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