MAUDE Adverse Event Report: STERILMED, INC.; NLM

Model Number ETHB12LT

Device Problem Material Integrity Problem (2978)

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

Event Type  malfunction  

Event Description

It was reported that the lock was broken on the device.There was no patient injury.This report is being filed for the findings upon investigation.Additional information was requested, but no additional information was available.

Manufacturer Narrative

Final device investigation found that the sleeve of an ethb12lt was returned with the obturator and stability cone of an ethh12lp.The sleeve had blood residue indicating clinical use.Upon evaluation, the locking mechanism of the sleeve operated as intended.However, the locking mechanism of the stability cone did not function due to what appeared to be excessive wear on the mechanism parts.The sleeve was then pressure tested.The sleeve showed no signs of leaking when tested along, but did show signs of leaking when a test obturator was inserted into the device.No lot number was provided with the device, so the device history record could not be reviewed for discrepancies.

• Brand Name: NA
• Type of Device: NLM
• Manufacturer (Section D): STERILMED, INC.; maple grove MN
• Manufacturer Contact: tricia schrater ; 11400 73rd ave. north; maple grove, MN 55369 ; 7634883211
• MDR Report Key: 3880980
• MDR Text Key: 18539907
• Report Number: 2134070-2014-00066
• Device Sequence Number: 1
• Product Code: NLM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052299
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/09/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ETHB12LT
• Device Catalogue Number: B12LT
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1