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

Model Number 175 030

Device Problem Difficult to Open or Close (2921)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/08/2020

Event Type  malfunction  

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 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
• Type of Device: 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
• Manufacturer (Section G): BEMIS DE MEXICO, SA DE CV; av texas #200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• Manufacturer Contact: rodolfo villarreal ; av texas #200; parque industrial nacional; cienega de flores, nuevo leon 65550 ; MX 65550
• MDR Report Key: 10577120
• MDR Text Key: 208344708
• Report Number: 3011198121-2020-00001
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 00073088149282
• UDI-Public: 0073088149282
• 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: distributor,health profession
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 175 030
• Device Catalogue Number: 175 030
• Device Lot Number: 188191
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/23/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/23/2020
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Yes
• 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