MAUDE Adverse Event Report: SPS MEDICAL MCKESSON BRANDED SCBI; BIOLOGICAL INDICATOR

Model Number 73-SCS025

Device Problems Break (1069); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Abrasion (1689)

Event Date 08/15/2018

Event Type  Injury  

Manufacturer Narrative

It was reported an employee received a few abrasions on her neck after glass shattered from a self-contained steam biological indicator (bi).It was reported the employee pulled the (bi) that was still warm to the touch from the autoclave after waiting twenty minutes to crack it before transferring the bi to the incubator.When she cracked the bi it shattered and it was reported a few shards of glass caused abrasions on her neck.It was reported the employee is a new user to this device and was not wearing the correct ppe.She did not seek medical attention and is reported to be fine.This is an isolated incident, there has been no other reported events.This complaint will continue to be monitored in the sps complaint system.

Event Description

It was reported an employee received a few abrasions on her neck after glass shattered from a self-contained steam biological indicator (bi).

Manufacturer Narrative

The part number and description have been updated.

• Brand Name: MCKESSON BRANDED SCBI
• Type of Device: BIOLOGICAL INDICATOR
• Manufacturer (Section D): SPS MEDICAL; 31 water street #1; cuba NY 14727
• MDR Report Key: 7878208
• MDR Text Key: 120322537
• Report Number: 1319130-2018-00002
• Device Sequence Number: 1
• Product Code: FRC
• Combination Product (y/n): N
• PMA/PMN Number: K111515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,user facility
• Type of Report: Initial,Followup
• Report Date: 09/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Expiration Date: 03/31/2020
• Device Model Number: 73-SCS025
• Device Lot Number: 6743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/28/2018
• Initial Date Manufacturer Received: 08/15/2018
• Initial Date FDA Received: 09/14/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 07/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other