MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE EXTREMITY PACK; ORTHOPEDIC TRAY

Catalog Number DYNJ42546B

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 06/25/2019

Event Type  malfunction  

Event Description

Black hair was found in basin from extremity pack when opening for case.The pack was removed from the room and a new one was opened.The pt was not in the room.Pt is here for right ankle peroneal tendon repair.

• Brand Name: MEDLINE EXTREMITY PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.
• MDR Report Key: 8785832
• MDR Text Key: 151291570
• Report Number: MW5088063
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ42546B
• Device Lot Number: 19CBH393
• 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
• Patient Age: 78 YR