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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SHARPS COLL II BD 7L; SHARPS CONTAINER
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BECTON DICKINSON IND. CIRURGICAS LTDA SHARPS COLL II BD 7L; SHARPS CONTAINER Back to Search Results
Catalog Number 305643
Device Problem Defective Component (2292)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2022
Event Type  malfunction  
Event Description
It was reported that the sharps coll ii bd 7l lid did not fit correctly and broke frequently.The following information was provided by the initial reporter: descartex with a lid that does not fit correctly, causing the lid to break frequently.
 
Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
 
Manufacturer Narrative
H6: investigation summary video and photo received by our quality team for investigation.Upon visual inspection, it was possible to observe difficulty in closure of the container.Possible root cause is associated with resistance of the mold manifold of the latex lid.The lid did not reach the appropriate temperature, causing the lid to be dimensionally millimeters smaller than specified.Action was taken immediately to correct the issue.Batch history analysis 2118502 - the batch history was checked, and it was noted that the production period occurred on (b)(6) 2022.The in-process inspections were performed according to the control plan and no records of this incident were evidenced.We inform that the current controls to detect the incident are performed through visual inspection in 100% of the parts in the manufacturing process.No quality occurrences related to the lot number supplied were observed.H3 other text : see h10.
 
Event Description
It was reported that the sharps coll ii bd 7l lid did not fit correctly and broke frequently.The following information was provided by the initial reporter: descartex with a lid that does not fit correctly, causing the lid to break frequently.
 
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Brand Name
SHARPS COLL II BD 7L
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
Manufacturer (Section G)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key15234302
MDR Text Key303170415
Report Number3003916417-2022-00149
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 08/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number305643
Device Lot Number2118502
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/30/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/28/2022
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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