MAUDE Adverse Event Report: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA KIT

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 09/10/2020

Event Type  Injury  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.The initial reporter also notified the fda on 31 august, 2020.Medwatch report # 1000870000-2020-8058.Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear anesthesia was ineffective.This was discovered after use.The following information was provided by the initial reporter: material no: 400866 batch no: unknown.It was reported that the anesthesia was ineffective.Event description per email states: a patient about to undergo total knew revision, was administered spinal anesthesia prior to the case.However, the spinal failed, and the patient went on to have general regional anesthesia.The operative note indicates "the patient was taken to the operating theater where spinal was performed.She still had some pain and therefore general anesthesia was induced." the procedure was carried out with no complications.What was the original intended procedure? revision right total knee arthroplasty what problem did the user have: device failed.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear anesthesia was ineffective.This was discovered after use.The following information was provided by the initial reporter: material no: 400866, batch no: unknown.It was reported that the anesthesia was ineffective.Event description per email states: a patient about to undergo total knew revision, was administered spinal anesthesia prior to the case.However, the spinal failed, and the patient went on to have general regional anesthesia.The operative note indicates "the patient was taken to the operating theater where spinal was performed.She still had some pain and therefore general anesthesia was induced." the procedure was carried out with no complications.What was the original intended procedure? revision right total knee arthroplasty what problem did the user have: device failed.

Manufacturer Narrative

The following fields have been updated with corrections: b.3.Date of event: (b)(6) 2020.The date received by manufacturer has been used for this field.G.4.Date received by manufacturer: 2020-09-10.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear anesthesia was ineffective.This was discovered after use.The following information was provided by the initial reporter: material no: 400866 batch no: unknown it was reported that the anesthesia was ineffective.Event description per email states: a patient about to undergo total knew revision, was administered spinal anesthesia prior to the case.However, the spinal failed, and the patient went on to have general regional anesthesia.The operative note indicates "the patient was taken to the operating theater where spinal was performed.She still had some pain and therefore general anesthesia was induced." the procedure was carried out with no complications.What was the original intended procedure? revision right total knee arthroplasty what problem did the user have: device failed.

Manufacturer Narrative

H6: investigation summary: a review of the device history record could not be performed since the mannford kit lot number was not provided.No samples were returned for evaluation.A photograph of the sample was provided.The photograph demonstrated an empty broken vial.The photograph did not allow for an evaluation of the drug.The failure mode could not be confirmed through sample analysis.The investigation was not able to identify or confirm any contribution to the reported failure mode from manufacturing.Per an inspection of the retain samples for vendor lot# 010053a, the color and overall appearance are acceptable for drug part #8301694.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.Lastly, the supplier was notified for drug potency results for the indicated vendor lot.Supplier (pfizer) returned acceptable potency results for the identified lot.All indicators suggest product 400866 contained a drug with acceptable potency.Based on the complaint investigation, the failure mode could not be confirmed and as a result a probable root cause could not be identified.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any actions for this complaint.H3 other text : see h10.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 10571320
• MDR Text Key: 208097684
• Report Number: 1625685-2020-00087
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 400866
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 50 YR
• Patient Weight: 70