MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MINOR VASCULAR PACK-LF; ENERAL SURGERY TRAY

Catalog Number CMPJ08204B

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 08/28/2020

Event Type  malfunction  

Event Description

Upon opening a minor vascular pack, a sterile surgical gown was noted to have a bug wing on the sleeve.Fda safety report id# (b)(4).

• Brand Name: MINOR VASCULAR PACK-LF
• Type of Device: ENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 10501202
• MDR Text Key: 206147982
• Report Number: MW5096447
• Device Sequence Number: 1
• Product Code: LRO
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: CMPJ08204B
• Device Lot Number: 20ABF770
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1