MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LUMBAR LAMINECTOMY-LF; ORTHOPEDIC TRAY

Model Number DYNJ53477D

Device Problems Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)

Patient Problem No Patient Involvement (2645)

Event Date 10/11/2019

Event Type  malfunction  

Event Description

Surgical technician was opening a lumbar laminectomy-lf packet and was taking the suction catheters out.Within the sterile suction catheter packet was what looked like dead skin cells or a dead bug.The package was not opened and was handed off the field, taken to the front desk, and replaced with a new one.

• Brand Name: LUMBAR LAMINECTOMY-LF
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; 1170 s northpoint blvd; waukegan IL 60085
• MDR Report Key: 9249842
• MDR Text Key: 164119360
• Report Number: 9249842
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: DYNJ53477D
• Device Catalogue Number: DYNJ53477D
• Device Lot Number: (10)19HBX025
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 10/29/2019
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 13140 DA