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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD DESCARTEX¿ II SHARPS COLLECTOR; SHARPS CONTAINER
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BECTON DICKINSON IND. CIRURGICAS LTDA BD DESCARTEX¿ II SHARPS COLLECTOR; SHARPS CONTAINER Back to Search Results
Catalog Number 305642
Device Problem Device Misassembled During Manufacturing /Shipping (2912)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/30/2022
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: na.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 difficult to close and cracked when forced.This complaint was created to capture the 2nd 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.".
 
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.H3 other text : see h.10.
 
Event Description
It was reported that the bd descartex¿ ii sharps collector lid was difficult to close and cracked when forced.This complaint was created to capture the 2nd 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.".
 
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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 Key14881592
MDR Text Key303248332
Report Number3003916417-2022-00106
Device Sequence Number1
Product Code MMK
Combination Product (y/n)N
Reporter Country CodeBR
PMA/PMN Number
NA
Number of Events Reported1
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 Received06/30/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305642
Device Lot Number1273453
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/30/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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