MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SHARPS COLL II BD 13L; SHARPS DISPOSAL

Catalog Number 305642

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 08/23/2022

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that during the assembly the bd sharps coll ii bd 13l broke in the center.The following information was provided by the initial reporter, translated from portuguese to english: during assembly attempt, the lid broke in its center in a way that material seems to has dried out.The professionals have had difficult to assemble the collector.

• Brand Name: BD SHARPS COLL II BD 13L
• Type of Device: SHARPS DISPOSAL
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 16368632
• MDR Text Key: 309668539
• Report Number: 3003916417-2023-00022
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/27/2023

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
• Device Operator: Other
• Device Catalogue Number: 305642
• Device Lot Number: 2089429
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/23/2023
• Initial Date FDA Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/30/2022
• 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
• Patient Sex: Female