MAUDE Adverse Event Report: NULL PORTEX SPINAL NEEDLES; ANESTHESIA CONDUCTION KIT

Catalog Number 100/496/122

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 10/18/2018

Event Type  malfunction  

Manufacturer Narrative

This mdr was generated under protocol b10009704 as a result of warning letter cms#: 617147.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.The device was received for evaluation.Visual and functional testing were performed.Visual inspection confirmed that the needle had become detached from the needle hub.No issues were found with the introducer needle which was returned.The incoming inspection records were reviewed.No issues were found during inspection.The supplier of the needle which was returned from the customer was made aware of this issue and a supplier corrective action report was issued to the supplier.The root cause of the issue could not be determined.This issue will be monitored for any increase in occurrence.If the occurrence of this issue increases significantly, additional investigative action will be taken.No product information has been provided to date.

Event Description

It was reported that after inserting the spinal needle, the clear hub breaks apart from the needle.No patient injury was reported.

• Brand Name: PORTEX SPINAL NEEDLES
• Type of Device: ANESTHESIA CONDUCTION KIT
• Manufacturer (Section G): NULL
• MDR Report Key: 15633885
• MDR Text Key: 307013891
• Report Number: 3012307300-2022-25143
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: DA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2023
• Device Catalogue Number: 100/496/122
• Device Lot Number: 3692561
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1