MAUDE Adverse Event Report: UNSPECIFIED BD¿ SPINAL TRAY; ANESTHESIA CONDUCTION KIT

Catalog Number UNKNOWN

Device Problem Patient-Device Incompatibility (2682)

Patient Problem Awareness during Anaesthesia (1707)

Event Date 08/13/2020

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: (b)(4).Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).

Event Description

It was reported that the anesthesia in the unspecified bd¿ spinal tray was ineffective during use on the patient.This complaint was created to capture the 5th of 5 related incidents.The following information was provided by the initial reporter: by failure we mean while placing the spinal everything seemed perfect but the spinal did not take effect properly.Doctor's spinal set in but then wore off very quickly.In my two one patient had good analgesia and were able to complete the surgery but they could still move their surgical leg.In another one dermatome wasn't numb but the rest of the abdomen was for a c-section.I also had another patient with a low spinal level where i had so supplement with ketamine.Another doctor also had 2 failures but i don't know the details.I think there is something wrong with the hyperbaric bupivacaine included in the kit.Its like the medication is not the correct potency so the patients are getting under dosed.

Event Description

It was reported that the anesthesia in the unspecified bd¿ spinal tray was ineffective during use on the patient.This complaint was created to capture the 5th of 5 related incidents.The following information was provided by the initial reporter: by failure we mean while placing the spinal everything seemed perfect but the spinal did not take effect properly.Doctor's spinal set in but then wore off very quickly.In my two one patient had good analgesia and were able to complete the surgery but they could still move their surgical leg.In another one dermatome wasn't numb but the rest of the abdomen was for a c-section.I also had another patient with a low spinal level where i had so supplement with ketamine.Another doctor also had 2 failures but i don't know the details.I think there is something wrong with the hyperbaric bupivacaine included in the kit.Its like the medication is not the correct potency so the patients are getting under dosed.

Manufacturer Narrative

H.6.Investigation summary: a complaint sample was not provided for evaluation.Therefore, the reported failure mode could not be confirmed through a sample evaluation.A lot number was not provided, as a result a review was unable to be performed for the lot.The investigation is not able to identify or confirm any manufacturing contribution to the reported failure mode.All related indicators for this part suggest the product contains a drug with acceptable potency.Previous corrective actions 67717 has already been implemented for ineffective anesthesia.In addition, the manufacturing stability program runs a single lot each year to ensure internal processes have not affected the product.Since no probable root cause can be identified for this failure mode, the investigation is not able to identify any further corrective actions for this complaint.Based on past reported complaints for this product, even when unconfirmed, a supplier quality notification was sent to the vendor to notify them of related reported failure mode (ineffective anesthesia).This complaint will be entered into the complaint management system and will be tracked and trended for future occurrences and captured through the quality data analysis (qda) process if any adverse trend is identified.H3 other text : see h.10.

• Brand Name: UNSPECIFIED BD¿ SPINAL TRAY
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10489766
• MDR Text Key: 207030813
• Report Number: 2243072-2020-01362
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• 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: 10/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/13/2020
• 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): Other