MAUDE Adverse Event Report: ANESTHESIA KIT DURASAFE 17X3-1/2

Catalog Number 400713

Device Problem Leak/Splash (1354)

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

Event Date 01/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter additional phone#: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that anesthesia kit durasafe 17x3-1/2 leaked.The following information was provided by the initial reporter: it is detected one piece with its content leakage.

Event Description

It was reported that anesthesia kit durasafe 17x3-1/2 leaked.The following information was provided by the initial reporter: it is detected one piece with its content leakage.

Manufacturer Narrative

H6: investigation summary a complaint of leakage was received from the customer.A photo was provided to aid in the investigation of this defect.In the photo, leakage was observed.The customer complaint was confirmed.A device history record review was completed by our quality engineer team for provided lot number 0282424.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.

• Brand Name: ANESTHESIA KIT DURASAFE 17X3-1/2
• Type of Device: ANESTHESIA KIT
• MDR Report Key: 11674091
• MDR Text Key: 250369860
• Report Number: 9610847-2021-00145
• 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: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/01/2022
• Device Catalogue Number: 400713
• Device Lot Number: 0282424
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/06/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/07/2020
• 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