MAUDE Adverse Event Report: ANESTHESIA KIT DURASAFE 18X3-1/2; ANESTHESIA CONDUCTION KIT

Catalog Number 400714

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/30/2020

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.

Event Description

It was reported that the anesthesia kit durasafe 18x3-1/2 experienced leakage prior to use.The following information was provided by the initial reporter: product presents spill.

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 9176684 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To further investigate this issue, one picture sample was provided for evaluation by our quality engineer team.The picture sample displayed signs of leakage within the product packaging.As our quality team handles the final packaging only for this product, a notification has been sent to the supplier of the related kit components that may have contributed to the observed leakage.At this time, a definite cause for the issue has not been determined.Our quality team will continue to monitor the production process for signs of this potential defect.H3 other text : see h.10.

Event Description

It was reported that the anesthesia kit durasafe 18x3-1/2 experienced leakage prior to use.The following information was provided by the initial reporter: product presents spill.

• Brand Name: ANESTHESIA KIT DURASAFE 18X3-1/2
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 9759359
• MDR Text Key: 191670955
• Report Number: 9610847-2020-00062
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/01/2021
• Device Catalogue Number: 400714
• Device Lot Number: 9176684
• Initial Date Manufacturer Received: 02/06/2020
• Initial Date FDA Received: 02/26/2020
• Supplement Dates Manufacturer Received: 02/06/2020
• Supplement Dates FDA Received: 02/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2019
• 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
• Patient Outcome(s): Other