MAUDE Adverse Event Report: ANESTHESIA 17GAX18CM DURASAFE; ANESTHESIA CONDUCTION KIT

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that the anesthesia 17gax18cm durasafe spinal needle and syringe were not connected properly and leaked during the injection.This event reportedly occurred 740 different times.The following information was provided by the initial reporter, translated from chinese to english: "the complaint was mainly about interface connection and liquid leakage (the spinal needle and syringe are often not connected tightly, resulting in air being drawn back and liquid leakage during bolus injection), on (b)(6) 2020, the department reported that the same situation occurred again, and reported that it had tried this situation before.".

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9319723.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.See h.10.

Event Description

It was reported that the anesthesia 17gax18cm durasafe spinal needle and syringe were not connected properly and leaked during the injection.This event reportedly occurred 740 different times.The following information was provided by the initial reporter, translated from chinese to english: "the complaint was mainly about interface connection and liquid leakage (the spinal needle and syringe are often not connected tightly, resulting in air being drawn back and liquid leakage during bolus injection), on october 26, the department reported that the same situation occurred again, and reported that it had tried this situation before.".

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10880889
• MDR Text Key: 226865494
• Report Number: 3006948883-2020-00801
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/21/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 9319723
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1