MAUDE Adverse Event Report: BEMIS DE MEXICO, SA DE CV BEMIS SENTINEL; SHARPS CONTAINER

Model Number	175 030
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From both the unused samples provided by complainant, and from retains of similar product by importer, it was established that there are aesthetic defects resulting from improper molding practices.However, we could not establish why the complainant was experiencing fitment issues of the lid to the container base, or of the locking rotor in the lid.Analysis of those parts is included with this report.
Event or Problem Description
Distributor reported customer was having a problem with 175 030 sharps containers.Customer reports tops are thin and do not secure properly to the base to provide a closed unit when done.Tops keep popping off and cause needles to go all over the floor.

• Brand Name: BEMIS SENTINEL
• Common Device Name: SHARPS CONTAINER
• Manufacturer (Section D): BEMIS DE MEXICO, SA DE CV; av texas #200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• MDR Report Key: 10577120
• Report Number: 3011198121-2020-00001
• Device Sequence Number: 1192285
• Product Code: MMK
• UDI-Device Identifier: 00073088149282
• UDI-Public: 0073088149282
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K953797
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 09/23/2020
• Report Date (Section F): 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 175 030
• Device Catalogue Number: 175 030
• Device Lot Number: 188191
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/23/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 09/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/23/2020