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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA KIT
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25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR; ANESTHESIA KIT Back to Search Results
Catalog Number 400866
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Awareness during Anaesthesia (1707); Pain (1994)
Event Date 07/17/2020
Event Type  malfunction  
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.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)(6).
 
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: 0001345574.It was reported that the failed spinal was converted to general anesthesia.Verbatim: failed spine that converted to general anesthesia.Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8ml of 0.75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg fentanyl (aoc0091, exp 2020-12).The patient tolerated the c-section until fascia.Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7 placed in trendelenburg.Patient passed surgeon testing but did not tolerate once they reached the fascial layer.Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position.Time out was taken and verified x3.At 0949 a pfannensteil incision was made with a scapel, and carried down to the fascia with electrocautery.Due to excessive pain, anesthesia converted to general with the glide scope at 1003.The c-section was carried out with no complications.
 
Manufacturer Narrative
The following fields have been updated with additional information: b.3.Date of event: (b)(6) 2020.
 
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: 0001345574.It was reported that the failed spinal was converted to general anesthesia.Verbatim: failed spine that converted to general anesthesia.Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8ml of 0.75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg fentanyl (aoc0091, exp 2020-12).The patient tolerated the c-section until fascia.Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7 placed in trendelenburg.Patient passed surgeon testing but did not tolerate once they reached the fascial layer.Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position.Time out was taken and verified x3.At 0949 a pfannensteil incision was made with a scapel, and carried down to the fascia with electrocautery.Due to excessive pain, anesthesia converted to general with the glide scope at 1003.The c-section was carried out with no complications.
 
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: 0001345574.It was reported that the failed spinal was converted to general anesthesia.Verbatim: failed spine that converted to general anesthesia.Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8ml of 0.75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg fentanyl (aoc0091, exp 2020-12).The patient tolerated the c-section until fascia.Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7 placed in trendelenburg.Patient passed surgeon testing but did not tolerate once they reached the fascial layer.Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position.Time out was taken and verified x3.At 0949 a pfannensteil incision was made with a scapel, and carried down to the fascia with electrocautery.Due to excessive pain, anesthesia converted to general with the glide scope at 1003.The c-section was carried out with no complications.
 
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.
 
Manufacturer Narrative
H6: investigation summary a review of the device history record noted no issues relating to the reported failure mode for lot # 0001345574.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 # 0001345574 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.Since no probable root cause was identified for this failure mode, the investigation was not able to identify any corrective actions for this complaint.
 
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: 0001345574 it was reported that the failed spinal was converted to general anesthesia.Verbatim: failed spine that converted to general anesthesia.Easy spinal, first attempt with free flow of csf, positive swirl in syringe at beginning, middle and end of injection of 1/8ml of 0.75% marcaine (from pyxis), 200 mcg of duramorph and 10mcg fentanyl (aoc0091, exp 2020-12).The patient tolerated the c-section until fascia.Foley insertion tolerated, could not feel cold from prep, motor block slow to set up, patient level t6-7 placed in trendelenburg.Patient passed surgeon testing but did not tolerate once they reached the fascial layer.Patient was taken to the operating room where regional anesthesia was maintained and then prepped and drapped in the normal sterile fashion in the left lateral tilt position.Time out was taken and verified x3.At 0949 a pfannensteil incision was made with a scapel, and carried down to the fascia with electrocautery.Due to excessive pain, anesthesia converted to general with the glide scope at 1003.The c-section was carried out with no complications.
 
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Brand Name
25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
Type of Device
ANESTHESIA KIT
MDR Report Key10564353
MDR Text Key208491329
Report Number1625685-2020-00085
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup,Followup,Followup
Report Date 02/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/21/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date10/31/2021
Device Catalogue Number400866
Device Lot Number0001345574
Was Device Available for Evaluation? No
Date Manufacturer Received02/14/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured02/20/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age37 YR
Patient Weight90
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