MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE; NEEDLE, SUTURING, DISPOSABLE

Catalog Number DYNJNC10A

Device Problem Device Contamination with Body Fluid (2317)

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

Event Date 02/19/2022

Event Type  malfunction  

Event Description

While making a delivery table, a sterile/packages sharps holder was opened and placed on the delivery table.Upon opening the sharps holder, there was a hair, and skin inside the holder that was supposed to be clean/sterile/right out of the package.Pictures were taken, lot number taken down, all packages with that lot number were removed from the floor and sent to distribution.An email was sent out to staff with the lot number and stated to keep an eye out for any others with that lot number that may have been missed on the floor, not to use them and to send them to distribution if found.

• Brand Name: MEDLINE
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 13848021
• MDR Text Key: 287619724
• Report Number: 13848021
• Device Sequence Number: 1
• Product Code: GAB
• 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: 02/22/2022,02/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: DYNJNC10A
• Device Lot Number: 67021074507
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/22/2022
• Date Report to Manufacturer: 03/22/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 03/22/2022
• Type of Device Usage: Unknown
• Patient Sequence Number: 1