MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - SPT MEDLINE LAP CHOLE PACK; LAPAROSCOPY KIT

Lot Number 19HBK201

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 11/25/2019

Event Type  malfunction  

Event Description

Surgical team preparing for lap chole discovers long black hair in the sterile kit.Fda safety report id# (b)(4).

• Brand Name: MEDLINE LAP CHOLE PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - SPT; northfield IL 60093
• MDR Report Key: 9409959
• MDR Text Key: 169208471
• Report Number: MW5091392
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 12/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Lot Number: 19HBK201
• Was Device Available for Evaluation?: Yes
• 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
• Patient Outcome(s): Other
• Patient Age: 17 YR