MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC MEDLINE-PHS #000622359-010, TEMECULA, CA; MODULE CPC LAMINECTOMY

Lot Number 1175464

Device Problems Delivered as Unsterile Product (1421); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 05/04/2015

Event Type  malfunction  

Event Description

Since (b)(6) 2015, there were 9 occurrences of sterile laminectomy surgical packs having debris inside, rendering the pack non-sterile.Of importance, 3 surgical cases were stopped, and with a least one case, the pt was already anesthestitized prior to discovery.

• Brand Name: MEDLINE-PHS #000622359-010, TEMECULA, CA
• Type of Device: MODULE CPC LAMINECTOMY
• Manufacturer (Section D): MEDLINE INDUSTRIES INC; one medline pl; mundelein IL 60060
• MDR Report Key: 4774336
• MDR Text Key: 5802688
• Report Number: MW5042709
• Device Sequence Number: 1
• Product Code: LRY
• 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: 05/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 1175464
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other