MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD DESCARTEX¿ II; SHARPS COLLECTOR

Catalog Number 305642

Device Problem Material Integrity Problem (2978)

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

Event Date 07/18/2018

Event Type  malfunction  

Manufacturer Narrative

The date received by manufacturer has been used for this field.(b)(6).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 the bd descartex¿ ii had a damaged bracket.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Event Description

It was reported that the bd descartex ii had a damaged bracket.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Investigation summary: the actual sample was not returned but photos were returned for evaluation.Dhr review; maintenance records and quality notifications (qn´s) records were reviewed and no evidence was found to be related to the defect.Based on the complaint by the customer, the damage or defect was present in only one unit of the product, being a punctual occurrence.It was possible to confirm the broken edge defect according to the images provided by the customer.The malfunction may have occurred either at the supplier or internally.Based on the information provided it is not possible to determine the exact cause of the defect.Training is to be carried out with the operators, reinforced in the inspection and sorting processes, to minimize future occurrences related to the presented defect.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that the bd descartex¿ ii had a damaged bracket.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD DESCARTEX¿ II
• Type of Device: SHARPS COLLECTOR
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7758830
• MDR Text Key: 116715678
• Report Number: 3003916417-2018-00190
• Device Sequence Number: 1
• Product Code: MMK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 09/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305642
• Device Lot Number: 8109633
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other