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

Model Number	405727
Medical Device Problem Code	Packaging Problem (3007)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/05/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.".
Additional 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
• Common Device Name: ANESTHESIA TRAY
• MDR Report Key: 9753798
• Report Number: 2243072-2020-00285
• Device Sequence Number: 3432040
• Product Code: CAZ
• UDI-Device Identifier: 00382904057275
• UDI-Public: 00382904057275
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2020

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
• Operator of Device: 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
• Initial Date Received by Manufacturer: 02/05/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 02/26/2020
• Supplement Report FDA Received Date: 07/30/2020
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/04/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other