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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 Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/16/2022
Event Type  malfunction  
Event Description
It was reported that 6 bd descartex¿ ii sharps collectors had lids that didn't fit properly.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "2.Lot: 2069663 - item caps do not fit properly.6 units.".
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.
 
Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for evalution?: yes.D10: returned to manufacturer on: 07-nov-2022 h6: investigation summary sample and photos received by our quality team for investigation.Upon visual inspection, lid will not shut is confirmed.A device history review was performed for the reported lot 2069663, no deviations or non-conformances were identified during the manufacturing process that could have contributed to this issue.Based on the quality team¿s investigation, there was an operational failure due to not having made the correct scope.
 
Event Description
It was reported that 6 bd descartex¿ ii sharps collectors had lids that didn't fit properly.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "2.Lot: 2069663 - item caps do not fit properly.(b)(6)units.".
 
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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 Key15403046
MDR Text Key301645056
Report Number3003916417-2022-00186
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 11/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/12/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305642
Device Lot Number2069663
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Date Manufacturer Received11/08/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/10/2022
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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