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

Catalog Number 400714

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 07/27/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 14 anesthesia kit durasafe 18 x 3-1/2 were damaged, but still operable.The following information was provided by the initial reporter: "inner damage".

Manufacturer Narrative

H.6.Investigation: a device history record review was performed for provided lot number 0125707 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, four picture samples were returned for evaluation by our quality engineer team.However, the reported "inner damage" could not be identified through examination of the picture samples.Based on the investigation results, the complaint could not be confirmed and the root cause is undetermined.H3 other text : see h.10.

Event Description

It was reported that 14 anesthesia kit durasafe 18x3-1/2 were damaged, but still operable.The following information was provided by the initial reporter: "inner damage.".

• Brand Name: ANESTHESIA KIT DURASAFE 18X3-1/2
• Type of Device: ANESTHESIA TRAY
• MDR Report Key: 10418325
• MDR Text Key: 203880700
• Report Number: 9610847-2020-00247
• 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: 09/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/01/2022
• Device Catalogue Number: 400714
• Device Lot Number: 0125707
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2020
• 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
• Patient Outcome(s): Other