MAUDE Adverse Event Report: RICHARD ALLAN SCIENTIFIC OF THERMO SCIENTIFIC 10% NEUTRAL BUFFERED FORMALIN

Catalog Number 594801

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: 10% NEUTRAL BUFFERED FORMALIN
• Type of Device: 10% NEUTRAL BUFFERED FORMALIN
• Manufacturer (Section D): RICHARD ALLAN SCIENTIFIC OF THERMO SCIENTIFIC
• MDR Report Key: 5249587
• MDR Text Key: 32221049
• Report Number: MW5058076
• Device Sequence Number: 1
• Product Code: IFP
• 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: 594801
• 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