MAUDE Adverse Event Report: TRAY SPN WHIT25G3.5 L/B-D/E; ANESTHESIA CONDUCTION KIT

Model Number	405673
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	08/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Suspect product name and strength: bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine) 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.Fda device problem code: 2682.Fda patient problem code: 1707.
Event or Problem Description
It was reported that 4 trays spn whit25g3.5 l/b-d/e had ineffective anesthesia during use.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.Dr.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.Dr.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 or Problem Description
It was reported that 4 trays spn whit 25g3.5 l/b-d/e had ineffective anesthesia during use.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.Dr.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.Dr.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.
Additional Manufacturer Narrative
H.6.Investigation: 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, capa#67717, have 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.H3 other text : see h.10.
Additional Manufacturer Narrative
Correction: after further evaluation of the complaint, the investigation found that all indicators suggested the product contained a drug with acceptable potency.Therefore, the c tab suspect product bupivacaine hcl (0.75%) with dextrose (8.25%), 2 ml (marcaine) was erroneously reported.
Event or Problem Description
It was reported that 4 trays spn whit25g3.5 l/b-d/e had ineffective anesthesia during use.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.Dr.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.Dr.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.

• Brand Name: TRAY SPN WHIT25G3.5 L/B-D/E
• Common Device Name: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10487969
• Report Number: 1625685-2020-00081
• Device Sequence Number: 3056107
• Product Code: CAZ
• UDI-Device Identifier: 00382904056735
• UDI-Public: 00382904056735
• Combination Product (Y/N): Y
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DISCRETION
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 405673
• Device Catalogue Number: 405673
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/13/2020
• Supplement Date Received by Manufacturer: 08/13/2020; 10/07/2020
• Initial Report FDA Received Date: 09/03/2020
• Supplement Report FDA Received Date: 10/07/2020; 12/23/2020
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other