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

Catalog Number 305642

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 05/24/2022

Event Type  malfunction  

Event Description

It was reported that 1 bd descartex¿ ii sharps collector from lot 1273453 had a lid that was difficult to close and cracked when forced.Additionally, another collector lid from lot 1273459 was difficult to close as well.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the descartex ii bd 13l material has deviations in the closure of the container, they crack when they are forced and a part is released and they put on tape and if you force too much it ends up breaking.The part that has a problem is the cover of the material, it is used for the disposal of syringes, various substances and medicines are used because they are several hospitals to which the foundation supplies the material." "she even mentioned that with lot 1273459, she had difficulty closing the lid.But she managed to close it without cracking.She did not inform the day.".

Manufacturer Narrative

There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1273453.Medical device expiration date.Device manufacture date: 30-sep-2021.Medical device lot #: 1273459.Medical device expiration date.Device manufacture date: 30-sep-2021.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval: yes d.10.Returned to manufacturer on: 15-aug-2022 h.6.Investigation summary: the photos and samples provided by the client were evaluated and the incident could be confirmed.The analysis of the lot history (dhr), quality notification records and a deviation was found for this lot (200999896), which can confirm the incident pointed out by the customer, and also observed the maintenance occurrence (603862853 -fault temperature controller potentially related to the incident, because the resistance of the mold manifold of the descartex cover does not reach the cover temperature causing cover dimensional millimeters below the specified, but still causes difficulty in closing the cover.According to the maintenance order, the temperature was set to manual with 100% power.And there was also an operational failure for not having made the correct scope to contain the incident.

Event Description

It was reported that 1 bd descartex¿ ii sharps collector from lot 1273453 had a lid that was difficult to close and cracked when forced.Additionally, another collector lid from lot 1273459 was difficult to close as well.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "the descartex ii bd 13l material has deviations in the closure of the container, they crack when they are forced and a part is released and they put on tape and if you force too much it ends up breaking.The part that has a problem is the cover of the material, it is used for the disposal of syringes, various substances and medicines are used because they are several hospitals to which the foundation supplies the material.She even mentioned that with lot 1273459, she had difficulty closing the lid.But she managed to close it without cracking.She did not inform the day".

• Brand Name: BD DESCARTEX¿ II SHARPS COLLECTOR
• Type of Device: SHARPS CONTAINER
• 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: 14893135
• MDR Text Key: 300069813
• Report Number: 3003916417-2022-00107
• 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,Followup
• Report Date: 08/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305642
• Device Lot Number: SEE SECTION H10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• 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