MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN GYN LAPAROSCOPY LF; GYNECOLOGICAL LAPAROSCOPIC KIT

Catalog Number CMPJ37661G

Device Problems Product Quality Problem (1506); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem No Patient Involvement (2645)

Event Date 01/23/2020

Event Type  malfunction  

Event Description

Sticker was placed on outside of gyn laparoscopy pack stating the one item on the inside has an exp of 10/31/2019 (betadine solution), but once removed from the inside of pack, the expiration date would then be 08/31/2020.In order to remove the betadine, the sterile pack would have to be opened completely to get the item.Fda safety report id# (b)(4).

• Brand Name: GYN LAPAROSCOPY LF
• Type of Device: GYNECOLOGICAL LAPAROSCOPIC KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN
• MDR Report Key: 9671557
• MDR Text Key: 177995124
• Report Number: MW5092766
• Device Sequence Number: 1
• Product Code: OHD
• 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: 01/31/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Catalogue Number: CMPJ37661G
• Device Lot Number: 19CB0737
• 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 Age: 46 YR
• Patient Weight: 83