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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ STERILE SYRINGE CONVENIENCE TRAY PISTON SYRINGE

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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD¿ STERILE SYRINGE CONVENIENCE TRAY PISTON SYRINGE Back to Search Results
Model Number 305618
Device Problem Volume Accuracy Problem (1675)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/08/2022
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed. The date received by manufacturer has been used for this field.
 
Event Description
It was reported that while using a bd¿ sterile syringe convenience tray there were scale marking issues. The following information was provided by the initial reporter: container of (10) 30 cc syringes. Some syringes without cc markings and some the ink comes off with use.
 
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Brand NameBD¿ STERILE SYRINGE CONVENIENCE TRAY
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer (Section G)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX
Manufacturer Contact
phillip emmert
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key13558827
MDR Text Key286561069
Report Number9610847-2022-00070
Device Sequence Number1
Product Code FMF
UDI-Device Identifier30382903056188
UDI-Public30382903056188
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/10/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number305618
Device Catalogue Number305618
Device Lot Number1243122
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received03/10/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/03/2021
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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