MAUDE Adverse Event Report: TRAY SPN WHIT27G3.5; ANESTHESIA TRAY

Model Number 405727

Device Problem Packaging Problem (3007)

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

Event Date 02/05/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(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 tray spn whit 27g3.5 had compromised sterility.The following information was provided by the initial reporter: "sterile wrapping stuck on outer packaging.".

Event Description

It was reported that tray spn whit27g3.5 had compromised sterility.The following information was provided by the initial reporter: "sterile wrapping stuck on outer packaging.".

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/1/2020.H.6.Investigation: a device history record review of all applicable manufacturing records for the lot did not identify any issues that may have contributed to the reported failure during production.Samples were returned for evaluation.Two sample trays were provided, but only one tray had the tyvek web.Visual analysis of the sample shows a slight tear on wrap, confirming failure mode (package difficult to open/tears).The exposed seal around tyvek web and outer tray demonstrates no evidence of an open seal.It is possible that manufacturing personnel did not completely tighten wrap or firmly place wrapped tray in outer tray before sealing.The most probable root cause for the reported failure mode is that the wrap was loose before sealing operation causing wrap to slightly overlap outer tray.

• Brand Name: TRAY SPN WHIT27G3.5
• Type of Device: ANESTHESIA TRAY
• MDR Report Key: 9753798
• MDR Text Key: 184423869
• Report Number: 2243072-2020-00285
• Device Sequence Number: 1
• Product Code: CAZ
• UDI-Device Identifier: 00382904057275
• UDI-Public: 00382904057275
• 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: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 405727
• Device Catalogue Number: 405727
• Device Lot Number: 1262635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2020
• Date Manufacturer Received: 02/05/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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