MAUDE Adverse Event Report: ANESTHESIA TRAY BASIC SPINAL; ANESTHESIA CONDUCTION KIT

Catalog Number 401383

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2020

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 shipping box of anesthesia trays basic spinal was found "dirty/wet".The following information was provided by the initial reporter, translated from (b)(4) to english: "it was found in customer's warehouse the package dirty/wet, they believe it has come with the issue because no other product has been found with the same issue.".

Manufacturer Narrative

H.6.Investigation: a physical sample was not available for investigation but bd was provided with a photo of the issue for evaluation.A review of the device history record was performed for the reported lot, 9158555, and no quality issues were found during production.Our quality engineer reviewed the provided photo and observed that the package appeared to have a wet spot.Based off the provided photo the engineer was able to verify the reported defect.Unfortunately, a definitive root cause could not be determined.It was likely that this defect occurred either during transit or storage.

Event Description

It was reported that the shipping box of anesthesia trays basic spinal was found "dirty/wet".The following information was provided by the initial reporter, translated from portuguese to english: "it was found in customer's warehouse the package dirty/wet, they believe it has come with the issue because no other product has been found with the same issue.".

• Brand Name: ANESTHESIA TRAY BASIC SPINAL
• Type of Device: ANESTHESIA CONDUCTION KIT
• MDR Report Key: 10860818
• MDR Text Key: 217068368
• Report Number: 9610048-2020-00156
• 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: 12/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2021
• Device Catalogue Number: 401383
• Device Lot Number: 9158555
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/15/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/19/2019
• 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