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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
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BECTON DICKINSON IND. CIRURGICAS LTDA BD DESCARTEX¿ II SHARPS COLLECTOR Back to Search Results
Catalog Number 305642
Device Problem Component Missing (2306)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 09/26/2022
Event Type  malfunction  
Event Description
It was reported that 4 bd descartex¿ ii sharps collectors were missing lids.The following information was provided by the initial reporter, translated from portuguese: "when we opened the primary box, the absence and/or lack of 4 lids was identified, making it impossible to use the containers.".
 
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 have been updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 02-dec-2022.H.6.Investigation summary: sample and four photos received by our quality team for investigation.Upon visual inspection and evaluation, missing lids from the sharp containers were observed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the available information we are not able to identify a root cause related to the manufacturing process at this time.The process and inspections in process were carried out in accordance with the control plan and no records of this incident were evidenced.Please be advised that the current controls to detect the incident are carried out through visual inspection of 100% of the parts in the manufacturing process.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 4 bd descartex¿ ii sharps collectors were missing lids.The following information was provided by the initial reporter, translated from portuguese: "when we opened the primary box, the absence and/or lack of 4 lids was identified, making it impossible to use the containers.".
 
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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 Key15646254
MDR Text Key303167043
Report Number3003916417-2022-00232
Device Sequence Number1
Product Code MMK
UDI-Device Identifier07891463003850
UDI-Public(01)07891463003850
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 12/02/2022
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 Number305642
Device Lot Number2150318
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 09/26/2022
Initial Date FDA Received10/21/2022
Supplement Dates Manufacturer Received12/02/2022
Supplement Dates FDA Received12/13/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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