MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC SMITHS MEDICAL PORTEX NO EPI SPINAL KIT; NEEDLE, SPINAL, SHORT TERM

Model Number NEPI-NLD-15583C-21

Device Problem Therapeutic or Diagnostic Output Failure (3023)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  No Answer Provided  

Event Description

Smiths medical asd, inc portex no epinephrine spinal kit, nepi-nld-15583c-21 failed to work on multiple patients.The bupivicaine spinal ampule in the kit, which is 0.75% in dextrose 8.25% did not produce an effect in the patient.The lot number and expiration date for the spinal kits used is unfortunately were different but include lot numbers #3644572, exp: 03/01/2020.Lot#3702072, exp 06/01/2020 and lot #3630577, exp 03/01/2020.The product was properly stored at controlled room temperature and was intact at time of usage.Multiple anesthesiologists used the product which sometimes worked and sometimes did not, and unfortunately it wasn¿t just one lot # that was affected.The kits themselves appear to work but the bupivacaine in them is not effective.What we are not doing is using the kits but not using the supplies bupivacaine spinal, rather bupivacaine supplied by the pharmacy department.The patients were not complicated patients and did not have any anatomical issues that lead to spinal insertion complications.Due to complications from kits not working, the patients were forced to receive general anesthesia to finish procedure.We have 20 unopened kits we would love for the fda to evaluate.Dates of use: (b)(6) 2018 ¿ (b)(6) 2019.Event abated after use: yes.

• Brand Name: SMITHS MEDICAL PORTEX NO EPI SPINAL KIT
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC
• MDR Report Key: 8301232
• MDR Text Key: 135888033
• Report Number: MW5083652
• Device Sequence Number: 3
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 01/29/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2020
• Device Model Number: NEPI-NLD-15583C-21
• Device Lot Number: 3630577
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1