MAUDE Adverse Event Report: NULL PORTEX SPINAL NEEDLES; NEEDLE, SPINAL, SHORT TERM

Catalog Number 100/496/027

Device Problems Device Difficult to Setup or Prepare (1487); Material Separation (1562)

Patient Problem Paresthesia (4421)

Event Date 10/16/2021

Event Type  Injury  

Manufacturer Narrative

This remediation mdr was generated under protocol b10010116, as a result of warning letter cms# 617147.No investigation or root cause analysis could be conducted given that no complaint sample was returned.

Event Description

It was reported that there was difficult construction of the spinal cord anesthesia and 20 mm of the spinal needle broke off inside the patient.Patient indicated she has no back pain no sensory disturbances.Patient later reported of tingling sensation in right gluteal region.

• Brand Name: PORTEX SPINAL NEEDLES
• Type of Device: NEEDLE, SPINAL, SHORT TERM
• Manufacturer (Section G): NULL
• MDR Report Key: 16744238
• MDR Text Key: 313336864
• Report Number: 3012307300-2023-04140
• Device Sequence Number: 1
• Product Code: MIA
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K172800
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 100/496/027
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/11/2022
• 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
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention