MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS SENTINEL; SHARPS CONTAINER

Model Number 175 030

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 03/22/2016

Event Type  malfunction  

Manufacturer Narrative

Dhr reviewed and no nonconformity found.Customer supplied photos.

Event Description

Medical assistant states that after she put a syringe into the sharps container which had other syringes in it, she tapped the container and felt a sting.After removing gloves, she saw blood on the knuckle of her ring finger, right hand.User examined the container and found a syringe had poked through the container wall.

• Brand Name: BEMIS SENTINEL
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old county pp; sheboygan falls WI 53085 0901
• Manufacturer (Section G): BEMIS MANUFACTURING COMPANY; w2940 old county pp; sheboygan falls WI 53085 0901
• Manufacturer Contact: john cutting ; w2940 old county pp; sheboygan falls, WI 53085-0901 ; 9204678927
• MDR Report Key: 5538281
• MDR Text Key: 41562138
• Report Number: 2133713-2016-00001
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K953797
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Medical Assistant
• Device Model Number: 175 030
• Device Catalogue Number: 175 030
• Device Lot Number: 20150046
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1