MAUDE Adverse Event Report: BEMIS MANUFACTURING COMPANY BEMIS; WIRE WALL MOUNT BRACKET

Model Number 423 000

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

Patient Problem No Patient Involvement (2645)

Event Date 06/06/2020

Event Type  malfunction  

Event Description

Distributor reported that welds are breaking on metal sharps container wall mounting brackets.There was no patient involvement, no injury reported, and no report of broken sharps, or sharps exposure.

• Brand Name: BEMIS
• Type of Device: WIRE WALL MOUNT BRACKET
• Manufacturer (Section D): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls, wi
• Manufacturer (Section G): BEMIS MANUFACTURING COMPANY; w2940 old cty pp; sheboygan falls, wi
• Manufacturer Contact: john cutting ; w2940 old cty pp; sheboygan falls, wi ; 4678927
• MDR Report Key: 10181256
• MDR Text Key: 198906785
• Report Number: 2133713-2020-00001
• 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: distributor,user facility
• Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date: 06/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 423 000
• Device Catalogue Number: 423 000
• Was Device Available for Evaluation?: Yes
• Device Age: 5 MO
• Date Manufacturer Received: 06/06/2020
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1