MAUDE Adverse Event Report: SHARPS COMPLIANCE, INC. SHARPS 3 GALLON; SHARPS CONTAINER

Model Number 13000

Device Problems Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/08/2014

Event Type  Injury  

Event Description

On (b)(6) 2014 at 9 am, (b)(6), (with (b)(6)), called in to report an incident.Customer was carrying sharps container back to pharmacy and accidently bumped leg into bottom of container and customer was poked by needle that was protruding out of the bottom of the container.Container has been placed in a secure area so no one can access it.Customer did see a doctor and she has taken a blood test.She is currently awaiting results of this test to make sure no infection or disease was injected into her system.Per a1 we will send out customer item 12801 - 28 gallon medical professional sharps recovery system so that the contaminated container can be sent back for quality inspection.As of (b)(6) 2014, the container has not been returned to sharps.

Manufacturer Narrative

Investigation of actual container not possible due to container not returned to manufacturer.At such a time as sharps receives the container sharps will perform an investigation, including but not limited to the wall thickness of the section of the container where the needle is protruding.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 the review of previous needle protruding from container reports it is usually the container being overfilled that leads to needle protrusions.

• Brand Name: SHARPS 3 GALLON
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): SHARPS COMPLIANCE, INC.; houston TX
• Manufacturer Contact: aladwani ; 2730 reed rd.; houston, TX 77051 ; 7134433539
• MDR Report Key: 4170550
• MDR Text Key: 5157105
• Report Number: 3007508552-2014-00002
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,other
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 12/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2014
• Is this an Adverse Event Report?: Yes
• Device Operator: Other
• Device Model Number: 13000
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/05/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other