MAUDE Adverse Event Report: CARDINAL HEALTH; CONTAINER

Catalog Number C4320-450B MNF

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

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

Event Type  malfunction  

Event Description

Since (b)(6) 2014, there has been an increase in exposure to formalin due to container spills and leakage from the prefilled specimen containers.Leaking containers occur both on the initial handling of containers by the materials management staff as well as when resealing after the specimen has been added.The materials management team has communicated with the vendor and returned two specimen containers to the vendor for eval.

• Brand Name: UNK
• Type of Device: CONTAINER
• Manufacturer (Section D): CARDINAL HEALTH
• MDR Report Key: 5249587
• MDR Text Key: 32221049
• Report Number: MW5058076
• Device Sequence Number: 2
• Product Code: MMK
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/19/2015
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: C4320-450B MNF
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/19/2015
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1