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

Model Number	100015
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/07/2016
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Sharps product packaging facility, located at (b)(4) does not allow for contaminants in product packaging areas.Containers are wrapped in plastic from the supplier, until they reach the product packaging area.Containers are then inspected for an absorbent pad, and to make sure there are no contaminants immediately prior to being placed into a 4 mil plastic bag and then into corrugate packaging.Packaged product is palletized and moved to a finished good location until needed for shipping.Product packaging is supervised by a line leader and numerous line workers.At no point following product packaging is the 4 mil plastic bag opened until reaching the customer or distributor.At no point in the product packaging process is there a potential for contaminants to be placed into sharps containers.Sharps does not treat used containers/systems at their product packaging facility.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) 2016 at 4: pm - (b)(6) from (b)(6) called (b)(4) at sharps compliance, inc., customer support and stated 3-gallon replacement return box received and it included a 1 quart sharps container manifest (b)(4).She also stated that she was stuck by a needle that protruded through the 1-quart container.On (b)(4) 2016 at 4:15 pm - (b)(4) contacted (b)(4) of quality at sharps compliance, inc., (b)(4) instructed (b)(4) to contact (b)(6) at (b)(6) and explain the following: (b)(6) should seek medical attention and inform (b)(6)'s safety officer of this incident.Sharps to ship a larger containment system to retrieve the suspected container for further investigation.Upon receipt of returned container, sharps will investigate and the results of that investigation will be reported to (b)(6).On (b)(4) 2016 - review of sharps environmental services treatment records show that the system in question was returned directly to sharps environmental services (b)(4), (treatment facility) and treated on (b)(4) 2016, instead of being returned to sharps compliance for inspection in the provided, postage prepaid 20-gallon return system.No further inspection possible.On (b)(6) 2016 about 11:10 - (b)(6) returned contacted mr.(b)(4) (from phone # (b)(6)) and explained the following: while attempting to place the 1 quart container inside the 3 gallon mailback box she was stuck by a needle protruding "thru" the container and she was able to seek medical help.The needle stuck her right hand index finger.(b)(6) also explained that her position is (b)(6) and stated "i am not familiar the containers or how to ship back".

• Brand Name: SHARPS COMPLIANCE, INC.
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): SHARPS COMPLIANCE, INC.; 2730 reed rd.; suite 200; houston TX 77051
• MDR Report Key: 8032235
• Report Number: 3007508552-2016-00001
• Device Sequence Number: 16510212
• Product Code: FMI
• UDI-Device Identifier: 00634188000905
• UDI-Public: 00634188000905
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• PMA/510(K) Number: K945275
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Administrator/Supervisor
• 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: Lay User/Patient
• Device Model Number: 100015
• Device Catalogue Number: 100015
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2016
• Initial Report FDA Received Date: 11/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other