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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 MAX UVE SPECIMEN COLLECTION KIT; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD MAX UVE SPECIMEN COLLECTION KIT; TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM Back to Search Results
Model Number 443376
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/17/2021
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that while using bd max¿ uve specimen collection kit incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the client notes that the expiration date is different in the media from the one reported in the collection swab from the one reported on the package.".
 
Manufacturer Narrative
This mdr should be considered cancelled.This type of kit has an expiration date on the components and a separate expiration date for the kit as a whole.This is not a product error and the expiration date on the kit should be followed.
 
Event Description
It was reported that while using bd max¿ uve specimen collection kit incorrect label information was observed by the laboratory personnel.There was no report of patient impact.The following information was provided by the initial reporter: "the client notes that the expiration date is different in the media from the one reported in the collection swab from the one reported on the package.".
 
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Brand Name
BD MAX UVE SPECIMEN COLLECTION KIT
Type of Device
TRICHOMONAS VAGINALIS NUCLEIC ACID AMPLIFICATION TEST SYSTEM
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key12178034
MDR Text Key261840473
Report Number9610847-2021-00330
Device Sequence Number1
Product Code OUY
UDI-Device Identifier30382904433766
UDI-Public30382904433766
Combination Product (y/n)N
PMA/PMN Number
K151589
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/09/2021
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 Expiration Date11/19/2021
Device Model Number443376
Device Catalogue Number443376
Device Lot Number0063350
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 06/17/2021
Initial Date FDA Received07/15/2021
Supplement Dates Manufacturer Received06/17/2021
Supplement Dates FDA Received08/09/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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