MAUDE Adverse Event Report: NULL PORTEX LANCET POINT SPINAL NEEDLES WITH NRFIT; NEEDLE, SPINAL, SHORT TERM

Catalog Number NEPI-NLD-15597-20

Device Problem Failure to Deliver (2338)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/10/2021

Event Type  malfunction  

Manufacturer Narrative

Review of device history records and incoming records found no discrepancies or anomalies relevant to the complaint.Assay testing, performed by the supplier prior to release of bupivacaine was within specification.Review of the sterilization certificate for the tray revealed that the product was processed according to validated specification requirements and parameters.The manufacture periodically monitors supplied drug components stability post ethylene oxide sterilization throughout their expiry.Our records show that the supplied drug components continue to meet potency specifications.Complaint information review found no trends relevant to the drug lot number, reported in this complaint.The anesthetics are supplied items and the complaint notification was forwarded to the supplier.Based on available information and evidences no product quality problem could be confirmed.Possible causes of lack of effect may be administration technique or patient anatomical variations, including pathological or psychological factors.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).

Event Description

It was reported that the anesthesiologist performed a perfect spinal block for a c-section with visual cerebrospinal fluid flashback but there was no sensory change in the patient.The procedure was switched to general anesthesia to complete the procedure.The bupivacaine must have failed.No patient injury was reported.

• Brand Name: PORTEX LANCET POINT SPINAL NEEDLES WITH NRFIT
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 15422990
• MDR Text Key: 306245897
• Report Number: 3012307300-2022-19214
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: NEPI-NLD-15597-20
• Device Lot Number: 4090672
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1