MAUDE Adverse Event Report: NULL PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS; Anesthesia conduction kit

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/20/2018

Event Type  malfunction  

Event Description

It was reported that the tip of the bevel of the yellow needle is bent over, causing it to be difficult to insert needle.Then when removing, tissue is being pulled because the needle is bent.

Manufacturer Narrative

This mdr was generated under protocol (b)(4) 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.A product sample was received for evaluation.Visual and functional testing were performed.Visual inspection the tip of the hypodermic needle was damaged (burred), thus confirming the complaint.During inspection of stock, in which samples from four different raw material lots were inspected; no issues or damage were observed with the samples from stock.While the damage to the returned used sample was observed, 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.

• Brand Name: PORTEX EPIDURAL CUSTOM CONTINUOUS TRAYS
• Type of Device: Anesthesia conduction kit
• Manufacturer (Section G): NULL
• MDR Report Key: 15591164
• MDR Text Key: 307021211
• Report Number: 3012307300-2022-23577
• Device Sequence Number: 1
• Product Code: CAZ
• 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: 10/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• 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