MAUDE Adverse Event Report: CARDINAL HEALTH 200 LLC GYN PACK (GYCTF) 839; GYNECOLOGICAL LAP KIT

Catalog Number SMA73GYCT2

Device Problems Incomplete or Missing Packaging (2312); Device Markings/Labelling Problem (2911)

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

Event Date 03/07/2019

Event Type  malfunction  

Event Description

Ob gyn pack with incorrect number of raytec sponges.Contents form states should have 10 sponges and there were only 9.

• Brand Name: GYN PACK (GYCTF) 839
• Type of Device: GYNECOLOGICAL LAP KIT
• Manufacturer (Section D): CARDINAL HEALTH 200 LLC
• MDR Report Key: 8470888
• MDR Text Key: 140771671
• Report Number: MW5085440
• 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: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2020
• Device Catalogue Number: SMA73GYCT2
• Device Lot Number: 978768
• Was Device Available for Evaluation?: No
• 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