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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BEMIS DE MEXICO, SA DE CV BEMIS SENTINEL; SHARPS CONTAINER

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BEMIS DE MEXICO, SA DE CV BEMIS SENTINEL; SHARPS CONTAINER Back to Search Results
Model Number 175 030
Device Problem Difficult to Open or Close (2921)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/08/2020
Event Type  malfunction  
Manufacturer Narrative
From both the unused samples provided by complainant, and from retains of similar product by importer, it was established that there are aesthetic defects resulting from improper molding practices.However, we could not establish why the complainant was experiencing fitment issues of the lid to the container base, or of the locking rotor in the lid.Analysis of those parts is included with this report.
 
Event Description
Distributor reported customer was having a problem with 175 030 sharps containers.Customer reports tops are thin and do not secure properly to the base to provide a closed unit when done.Tops keep popping off and cause needles to go all over the floor.
 
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Brand Name
BEMIS SENTINEL
Type of Device
SHARPS CONTAINER
Manufacturer (Section D)
BEMIS DE MEXICO, SA DE CV
av texas #200
parque industrial nacional
cienega de flores, nuevo leon 65550
MX  65550
Manufacturer (Section G)
BEMIS DE MEXICO, SA DE CV
av texas #200
parque industrial nacional
cienega de flores, nuevo leon 65550
MX   65550
Manufacturer Contact
rodolfo villarreal
av texas #200
parque industrial nacional
cienega de flores, nuevo leon 65550
MX   65550
MDR Report Key10577120
MDR Text Key208344708
Report Number3011198121-2020-00001
Device Sequence Number1
Product Code MMK
UDI-Device Identifier00073088149282
UDI-Public0073088149282
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K953797
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,health profession
Reporter Occupation Nurse
Type of Report Initial
Report Date 09/23/2020
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 Health Professional
Device Model Number175 030
Device Catalogue Number175 030
Device Lot Number188191
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2020
Event Location Outpatient Treatment Facility
Date Report to Manufacturer09/23/2020
Initial Date Manufacturer Received 09/08/2020
Initial Date FDA Received09/23/2020
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 Number1
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