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

Catalog Number 401622

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2021

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 experienced leakage.The following information was provided by the initial reporter: (b)(6) 2021 under intraspinal anesthesia [perianal] mixed hemorrhoids external peeling and internal ligation treatment, using consumables (one-time use anesthesia puncture kit) during anesthesia, put the spinal needle into the subarachnoid space, and withdraw the syringe.Unable to withdrawal the cerebrospinal fluid, some air was drawn back.After inspection, the syringe and spinal needle are poorly sealed.The spinal anesthesia needle in the disposable anesthesia puncture kit was replaced again.The spinal anesthesia needle withdrawn and injected medicine was normal.

Event Description

It was reported that the anesthesia 17gax18cm durasafe experienced leakage.The following information was provided by the initial reporter: (b)(6) 2021 under intraspinal anesthesia [perianal] mixed hemorrhoids external peeling and internal ligation treatment, using consumables (one-time use anesthesia puncture kit) during anesthesia, put the spinal needle into the subarachnoid space, and withdraw the syringe.Unable to withdrawal the cerebrospinal fluid, some air was drawn back.After inspection, the syringe and spinal needle are poorly sealed.The spinal anesthesia needle in the disposable anesthesia puncture kit was replaced again.The spinal anesthesia needle withdrawn and injected medicine was normal.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 0238682.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.H3 other text : see h.10.

• Brand Name: ANESTHESIA 17GAX18CM DURASAFE
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 11313875
• MDR Text Key: 232858911
• Report Number: 3006948883-2021-00224
• 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: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 401622
• Device Lot Number: 0238682
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2020
• 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