MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; GENERAL SURGERY TRAY

Model Number DYNDC2409A

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Patient arrived for infusion therapy.When prepping for infusion, the medline port access kit safety shield was already pulled over the needle prior to the package being opened.Costly product not able to be used.Manufacturer response for general surgery tray, medline industries, inc.(per site reporter).Will investigate.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl; mundelein IL 60060
• MDR Report Key: 13513682
• MDR Text Key: 285473243
• Report Number: 13513682
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10889942805693
• UDI-Public: (01)10889942805693(10)2021110390(17)230430
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/11/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNDC2409A
• Device Catalogue Number: DYNDC2409A
• Device Lot Number: 2021110390
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/07/2022
• Event Location: Hospital
• Date Report to Manufacturer: 02/11/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1