MAUDE Adverse Event Report: SHARPS COMPLIANCE, INC. SHARPS COMPLIANCE, INC.; SHARPS CONTAINER

Model Number	100008
Health Effect - Clinical Codes	Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Date of Event	09/20/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
All sharps containers are puncture resistant, not puncture proof.Product labeling on the container states "containers are puncture resistant, not necessarily puncture proof", and instructions for use state "do not overfill (fill line is noted on container label.) lid must fit down tightly." based on review of previous needle protruding from container reports it is usually the container being overfilled that leads to needle protrusions.
Event or Problem Description
On (b)(6) 2017- (b)(6) with (b)(6) pharmacy filed a complaint and stated the following: as (b)(6) was finishing up a flu clinic she was holding the sharps container in her hand.As she was walking (b)(6) noticed that she was stuck by a needle protruding thru the container.(b)(6) was stuck near the abdomen.On 09/26/2017 sharps shipped 2 replacement containers and an additional larger containment system to package and ship the suspected container with needle protruding through it.On 10/13/2017 - as of today the customer has yet to ship the larger containment system, with the suspect container inside, back to sharps.At such time as the suspect container is received from the customer an inspection of the suspect container will be performed and findings recorded in the complaint file.

• Brand Name: SHARPS COMPLIANCE, INC.
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): SHARPS COMPLIANCE, INC.; 2730 reed road; suite 200; houston TX 77051
• MDR Report Key: 8032240
• Report Number: 3007508552-2017-00001
• Device Sequence Number: 1643193
• Product Code: MMK
• UDI-Device Identifier: 00634188000912
• UDI-Public: 00634188000912
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K083129
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 11/01/2018

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
• Operator of Device: Health Professional
• Device Model Number: 100008
• Device Catalogue Number: 100008
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other