MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY SENTINEL BY BEMIS 1QT PHLEBOTOMY CONTAINER; SHARPS CONTAINER

Model Number 100 030

Device Problem Material Puncture/Hole (1504)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/11/2016

Event Type  malfunction  

Manufacturer Narrative

Device history record for lot was reviewed and no discrepancies were found.

Event Description

Complainant stated that when a maintenance person was transporting a 1 quart sharps container to their holding area for disposal, he was stuck by a needle that was protruding out the side of the container.He is now going through their needlestick protocol.

• Brand Name: SENTINEL BY BEMIS 1QT PHLEBOTOMY CONTAINER
• Type of Device: SHARPS CONTAINER
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls WI 53085 0901
• Manufacturer (Section G): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls WI 53085 0901
• Manufacturer Contact: john cutting ; w2940 old cty pp; sheboygan falls, WI 53085-0901 ; 9204678927
• MDR Report Key: 5604200
• MDR Text Key: 43493999
• Report Number: 2133713-2016-00003
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K960525
• 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: 04/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Model Number: 100 030
• Device Catalogue Number: 100 030
• Device Lot Number: 20150035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2015
• 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