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

Catalog Number 400866

Device Problem Patient-Device Incompatibility (2682)

Patient Problems Awareness during Anaesthesia (1707); Pain (1994)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).Date of birth: unknown.The patient¿s age was used to determine a placeholder date.

Event Description

It was reported that 25gx3.5in whit 5ml glaspak bupi clear had ineffective anesthesia.The following information was provided by the initial reporter: "it was reported that the spinal anesthesia administered was ineffecive."verbatim - failed spinal - positive cerebrospinal fluid (csf) aspiration, 1.8ml 0.75% marcaine, 200 mcg duramorph, 10 mcg fentanyl given after positive csf aspiration.After medications were injected, again positive aspiration was noted as well.Spinal not adequate for surgery, general anesthesia needed.Note from the operative report: "the patient was taken to the operating room where spinal anesthesia was administered, but was not adequate to control the pain.She had to be converted to general".There were no complications noted".

Event Description

It was reported, that 25gx3.5in whit 5ml glaspak bupi clear.Had ineffective anesthesia.The following information was provided by the initial reporter: it was reported, that the spinal anesthesia administered was ineffecive."verbatim: failed spinal.Positive cerebrospinal fluid (csf) aspiration, 1.8ml 0.75% marcaine, 200 mcg duramorph, 10 mcg fentanyl, given after positive csf aspiration.After medications were injected, again positive aspiration was noted as well.Spinal not adequate for surgery, general anesthesia needed.Note from the operative report: "the patient was taken to the operating room, where spinal anesthesia was administered, but was not adequate to control the pain.She had to be converted to general".There were no complications noted.

Manufacturer Narrative

Investigation summary: a review of the device history record noted, no issues relating to the reported failure mode for 400866 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.Ram returned acceptable results.Consequently, the investigation was not able to confirm, the reported failure mode.

• Brand Name: 25GX3.5IN WHIT 5ML GLASPAK BUPI CLEAR
• Type of Device: ANESTHESIA SYRINGE
• MDR Report Key: 10690607
• MDR Text Key: 246422655
• Report Number: 1625685-2020-00093
• 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
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 400866
• Device Lot Number: 0001345574
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 40 YR
• Patient Weight: 60