MAUDE Adverse Event Report: COV LP/LLC, CRYSTAL LAKE, MFG

Model Number 065

Device Problem Material Puncture/Hole (1504)

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

Event Type  malfunction  

Manufacturer Narrative

Submit date: 4/6/2017.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

The customer reports that the sharps container has been punctured.

Manufacturer Narrative

The device history records data was reviewed for lot # 173917 and no internal rejects were found during production of the lot.The potential root cause for the reported condition is customer misuse.The container was filled above the fill line as per complaint description.There is a warning on the label not to over fill which was not followed during use.Based on the existing controls, the internal reject and the complaint history review, no formal investigation is required at this time.This will be used for tracking and trending purposes.This issue has been determined to be an isolated event due to customer misuse.The container was filled above the fill line as per event description.There is no harm or injury reported for the complaint.If information is provided in the future, a supplemental report will be issued.

Event Description

The customer reports that the sharps container has been punctured.(customer misuse)-from (b)(4) the customer states; of hearing of a sharps container being punctured.It's clear from the warning on the label not to over fill it.The customer just wanted to make sure the manufacturer and you are aware of this in case it would isolated incident.

• Manufacturer (Section D): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer (Section G): COV LP/LLC, CRYSTAL LAKE, MFG; 815 tek dr; crystal lake IL 60014 8172
• Manufacturer Contact: edward almeida ; 15 hampshire street; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 6463436
• MDR Text Key: 72192631
• Report Number: 1424643-2017-05005
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 065
• Device Catalogue Number: 065
• Device Lot Number: 00173917
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1