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

Catalog Number 305642

Device Problem Component Incompatible (1108)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

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 the bd descartex¿ ii sharps collector lid was too small and did not fit.The following information was provided by the initial reporter, translated from portuguese: "when the employee went to install the material cover, it was as if it had dried out, they carried out the test in the warehouse and they noticed that the cover is smaller than the base.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 09-dec-2022.Sample and photos received by our quality team for investigation.Upon visual evaluation, the lids were received broken.The lids were evaluated and to break is necessary to apply great force due to the material being flexible.Break out force test were performed three times on the additional lids, results were within specification limits.Additionally, the lids were the correct size.A device history review was performed for the reported lot 2089429 no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the investigation results, no manufacturing related defects could be identified and therefore, a cause for the reported incident could not be determined.H3 other text : see h10.

Event Description

It was reported that the bd descartex¿ ii sharps collector lid was too small and did not fit.The following information was provided by the initial reporter, translated from portuguese: "when the employee went to install the material cover, it was as if it had dried out, they carried out the test in the warehouse and they noticed that the cover is smaller than the base.".

• Brand Name: BD DESCARTEX¿ II SHARPS COLLECTOR
• Type of Device: SHARPS COLLECTOR
• 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: 15584274
• MDR Text Key: 301943631
• Report Number: 3003916417-2022-00226
• Device Sequence Number: 1
• Product Code: MMK
• UDI-Device Identifier: 07891463003850
• UDI-Public: (01)07891463003850
• 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,Followup
• Report Date: 12/20/2022

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?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/19/2022
• Initial Date FDA Received: 10/11/2022
• Supplement Dates Manufacturer Received: 12/20/2022
• Supplement Dates FDA Received: 01/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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