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

Model Number	405699
Medical Device Problem Code	Measurement System Incompatibility (2982)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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 during use the marcaine in the anesthesia trays were ineffective with a bd tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial company reporter: (3 of 3) it was reported that there has been issues with the marcaine in the anesthesia trays not properly working as needed.The information provided by dr.Was as follows: thursday in a caesarean section administer the marcaine that comes in the tray, following the stipulated process and patient can lift the legs and report sensation in the area.He opened another tray and repeated the process, without obtaining results.On sunday, another of the anesthesiologists reports the same and the same result with a patient.Monday in am dr.Indicates the same thing happens to him, already aware of the event in the afternoon he uses the spinal bupivacaine that we have in the pharmacy ( due to the shortage that there was of the trays with the marcaina).None of the patients has tolerance to the anesthesia reported.On monday afternoon the doctor indicated the patient responded as expected.At the moment, they are using the trays and not the medication in them.
Additional Manufacturer Narrative
Investigation: a photo was provided for evaluation.Customer provided photographs were provided.Vial appears as intended with no obvious defects.Fluid appears to be clear.No avenue to evaluate drug potency without the physical sample.Failure mode could not be confirmed.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.As a preventive action, the vendor of the applicable drug component (hospira / pfizer) will be notified of the reported failure mode from the customer.A device history record review of all applicable manufacturing records for lot 0001270921 did not identify any issues that may have contributed to the reported failure mode.Based on the complaint investigation, a probable root cause could not be identified for the reported failure mode.The investigation identified a previous capa (capa 67717) performed by the bd anesthesia quality group that specifically investigated the ¿ineffective anesthesia¿ failure mode.Refer to capa 67717 for additional information regarding the outcome of the investigation.
Event or Problem Description
It was reported that during use the marcaine in the anesthesia trays were ineffective with a bd tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial company reporter: (3 of 3) it was reported that there has been issues with the marcaine in the anesthesia trays not properly working as needed.The information provided by dr.Was as follows: 1.Thursday in a caesarean section administer the marcaine that comes in the tray, following the stipulated process and patient can lift the legs and report sensation in the area.He opened another tray and repeated the process, without obtaining results.2.On sunday, another of the anesthesiologists reports the same and the same result with a patient.3.Monday in am dr.Indicates the same thing happens to him, already aware of the event in the afternoon he uses the spinal bupivacaine that we have in the pharmacy ( due to the shortage that there was of the trays with the marcaina).None of the patients has tolerance to the anesthesia reported.On monday afternoon the doctor indicated the patient responded as expected.At the moment, they are using the trays and not the medication in them.
Additional Manufacturer Narrative
H6 investigation: a photo was provided for evaluation.Customer provided photographs were provided.Vial appears as intended with no obvious defects.Fluid appears to be clear.No avenue to evaluate drug potency without the physical sample.Failure mode could not be confirmed.Over a period of more than 10 years, no test result from samples returned due to ineffective anesthesia has ever failed to meet specifications.The causes of ineffective anesthesia have been well documented in clinical literature for many years.Whereas a strong history of testing has supported that drug potency is not the cause, the actual cause may not always be ascertained.Bd has a long history of test results to support that drug potency issues have not been the cause of ineffective anesthesia events reported to bd through the complaint system.A device history record review of all applicable manufacturing records for lot 0001270921 did not identify any issues that may have contributed to the reported failure mode.
Event or Problem Description
It was reported that during use the marcaine in the anesthesia trays were ineffective with a bd tray spn whit27g3.5 l/b-d/e.The following information was provided by the initial company reporter: (3 of 3) it was reported that there has been issues with the marcaine in the anesthesia trays not properly working as needed.The information provided by dr.Was as follows: thursday in a caesarean section administer the marcaine that comes in the tray, following the stipulated process and patient can lift the legs and report sensation in the area.He opened another tray and repeated the process, without obtaining results.On sunday, another of the anesthesiologists reports the same and the same result with a patient.Monday in am dr.Indicates the same thing happens to him, already aware of the event in the afternoon he uses the spinal bupivacaine that we have in the pharmacy ( due to the shortage that there was of the trays with the marcaina).None of the patients has tolerance to the anesthesia reported.On monday afternoon the doctor indicated the patient responded as expected.At the moment, they are using the trays and not the medication in them.

• Brand Name: BD TRAY SPN WHIT27G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 8776594
• Report Number: 1625685-2019-00068
• Device Sequence Number: 2638523
• Product Code: CAZ
• UDI-Device Identifier: 00382904056995
• UDI-Public: 00382904056995
• Combination Product (Y/N): N
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/11/2021

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: Health Professional
• Device Expiration Date: 06/30/2020
• Device Model Number: 405699
• Device Catalogue Number: 405699
• Device Lot Number: 0001270921
• Initial Date Received by Manufacturer: 06/24/2019
• Supplement Date Received by Manufacturer: 06/24/2019; 02/11/2021
• Initial Report FDA Received Date: 07/10/2019
• Supplement Report FDA Received Date: 08/14/2019; 02/17/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2018
• 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