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

Model Number 405671

Device Problem Patient-Device Incompatibility (2682)

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

Event Date 01/09/2020

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: unknown a sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that the bupivacaine/dextrose/marcaine were ineffective with a bd tray spn whit25g3.5 l/b-d/e plast drape.The following information was provided by the initial reporter: it was reported the bupivacaine/dextrose/marcaine medication mixture in the spinal trays has been ineffective.I was informed by anesthesia yesterday that they have been experiencing issues with the bupivicaine/dextrose/marcaine medication mixture in our spinal trays over the last few weeks.They thought at first that it was a fluke but this week alone, multiple providers have had the same issue and they have had at least 6 occurrences this week alone where the block did not work and they needed to go and grab a individual ampule from our med cart to perform the block.What was relayed to me is that the block was performed and medication injected and then the patient was still able to feel and could lift their leg.When they used a single ampule from our cart, it worked fine.

Event Description

It was reported that the bupivacaine/dextrose/marcaine were ineffective with a bd tray spn whit 25g3.5 l/b-d/e plast drape.The following information was provided by the initial reporter: it was reported the bupivacaine/dextrose/marcaine medication mixture in the spinal trays has been ineffective.I was informed by anesthesia yesterday that they have been experiencing issues with the bupivicaine/dextrose/marcaine medication mixture in our spinal trays over the last few weeks.They thought at first that it was a fluke but this week alone, multiple providers have had the same issue and they have had at least 6 occurrences this week alone where the block did not work and they needed to go and grab a individual ampule from our med cart to perform the block.What was relayed to me is that the block was performed and medication injected and then the patient was still able to feel and could lift their leg.When they used a single ampule from our cart, it worked fine.

Manufacturer Narrative

H.6.Investigation summary: three samples were received for evaluation.Two samples from lot 0001317747 and one sample from lot 0001283925 were provided.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 and without any visible particulate matter.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.Likewise, the complaint will be entered into the complaint management system and will be tracked & trended for future occurrences and reviewed/investigated through the quality data analysis (qda) process if an adverse trend is identified.No lot was reported however, a device history record review was performed on each of the sample lots that were returned to (b)(6).Dhr review results offers no objective evidence that could be correlated to the reported complaint failure mode.H3 other text : see section h.10.

• Brand Name: BD TRAY SPN WHIT25G3.5 L/B-D/E PLAST DRAPE
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9647860
• MDR Text Key: 202232930
• Report Number: 1625685-2020-00011
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904056711
• UDI-Public: 00382904056711
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 405671
• Device Catalogue Number: 405671
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2020
• Date Manufacturer Received: 01/09/2020
• 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