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.Date of event: unknown.The date received by manufacturer has been used for this field.The initial reporter also notified the fda on 3 august, 2020.Medwatch report # (b)(4) 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.(b)(4).

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no: 400866 batch no: 0001311129.It was reported that the anesthesia was ineffective which required the procedure to be completed using general anesthesia.Event description per email states: 0630.Scheduled repeat cesarean section.Easy spinal, 1st attempt by crna.Free flowing cerebrospinal fluid (csf) drops and swirl in syringe ¿ 1.6ml of kit 0.75% bupivacaine + 10mcg fentanyl + 200mcg duramorph injected.Foley insertion tolerated, patient able to move legs and differentiate cold, touch, sharp.Lot # of spinal kit ¿ 0001311129.Patient had to have general anesthesia due to failed spinal.Notes from the operative report.¿the patient was taken to the operating room where spinal anesthesia was performed, seemingly without complication, but was noted to be not effective at this point.Anesthesia determined she would require general anesthesia.General anesthesia was initiated without complication.

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 during use.The following information was provided by the initial reporter: material no: 400866 batch no: 0001311129.It was reported that the anesthesia was ineffective which required the procedure to be completed using general anesthesia.Event description per email states: 0630.Scheduled repeat cesarean section.Easy spinal, 1st attempt by crna.Free flowing cerebrospinal fluid (csf) drops and swirl in syringe ¿ 1.6ml of kit 0.75% bupivacaine + 10mcg fentanyl + 200mcg duramorph injected.Foley insertion tolerated, patient able to move legs and differentiate cold, touch, sharp.Lot # of spinal kit ¿ 0001311129.Patient had to have general anesthesia due to failed spinal.Notes from the operative report.¿the patient was taken to the operating room where spinal anesthesia was performed, seemingly without complication, but was noted to be not effective at this point.Anesthesia determined she would require general anesthesia.¿.¿general anesthesia was initiated without complication.

Manufacturer Narrative

H6: investigation summary : a review of the device history record noted no issues relating to the reported failure mode for lot # 0001311129.No complaint sample or photo was provided for evaluation.Although a sample was not provided for evaluation, mannford¿s stability program runs a single lot each year to ensure our processes does not affect the drug potency.Stability program returned acceptable results.Consequently, the investigation was not able to confirm the reported failure mode.The investigation was not able to identify or confirm any contribution to the reported failure mode from the factors noted above.All indicators suggest product 400866 lot # 0001311129 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 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.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear anesthesia was ineffective.This was discovered during use.The following information was provided by the initial reporter: material no: 400866 batch no: 0001311129.It was reported that the anesthesia was ineffective which required the procedure to be completed using general anesthesia.Event description per email states: 0630.Scheduled repeat cesarean section.Easy spinal, 1st attempt by crna.Free flowing cerebrospinal fluid (csf) drops and swirl in syringe ¿ 1.6ml of kit 0.75% bupivacaine + 10mcg fentanyl + 200mcg duramorph injected.Foley insertion tolerated, patient able to move legs and differentiate cold, touch, sharp.Lot # of spinal kit ¿ 0001311129.Patient had to have general anesthesia due to failed spinal.Notes from the operative report.¿the patient was taken to the operating room where spinal anesthesia was performed, seemingly without complication, but was noted to be not effective at this point.Anesthesia determined she would require general anesthesia.¿ ¿general anesthesia was initiated without complication.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 10590747
• MDR Text Key: 208830063
• Report Number: 1625685-2020-00088
• 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: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 02/17/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2020
• 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: 400866
• Device Lot Number: 0001311129
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/11/2019
• 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: 26 YR
• Patient Weight: 75