MAUDE Adverse Event Report: MEDLINE INDUSTIRES - MUNDELEIN MEDLINE NEEDLE COUNTER 40CT, FOAM BLOCK/MAGNET NEEDLE, SUTURING, DISPOSABLE

Lot Number 67019054505

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Patient Involvement (2645)

Event Date 10/17/2019

Event Type  malfunction  

Event Description

Sterile pack opened for blepharoplasty, long black hair found on needle block. Fda safety report id# (b)(4).

• Brand Name: MEDLINE NEEDLE COUNTER 40CT, FOAM BLOCK/MAGNET
• Type of Device: NEEDLE, SUTURING, DISPOSABLE
• Manufacturer (Section D): MEDLINE INDUSTIRES - MUNDELEIN
• MDR Report Key: 9213918
• MDR Text Key: 163167764
• Report Number: MW5090495
• Device Sequence Number: 1
• Product Code: GAB
• Combination Product (y/n): N
• 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: 10/17/2019

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 10/18/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Lot Number: 67019054505
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage