MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. LAPAROSCOPIC PACKS; LAPAROSCOPIC KIT

Lot Number 19FBS646

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 11/04/2019

Event Type  No Answer Provided  

Event Description

Oily substance found on inner sterile laparoscopic pack wrapper.Fda safety report id (b)(4).

• Brand Name: LAPAROSCOPIC PACKS
• Type of Device: LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9290985
• MDR Text Key: 165775391
• Report Number: MW5090935
• Device Sequence Number: 1
• Product Code: FDE
• 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: 11/05/2019
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2023
• Device Lot Number: 19FBS646
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• 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