AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2012-10-31 for AFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT 446255 manufactured by Becton Dickinson Infusion Therapy Systems.

Event Text Entries

[2941064] A technician was processing a specimen for testing on the affirm system. The facility receives samples from many different doctors offices. This particular sample had shards of glass in it which the customer theorizes came from the broken transport ampule at the collection site with the glass making its way into the sample tube. The tech at the testing site cut her finger when she was squeezing the tube to dispense the sample for testing. The cut came from a shard of glass that poked through the plastic tube. The cut was washed and bandaged using basic first aid.
Patient Sequence No: 1, Text Type: D, B5


[10305614] This product contains an ampule of reagent. The ampule is crushed and the reagent is released through a dropper into a patient sample. Returns were unavailable for analysis. A review of the complaint notes indicates a misuse of the product where the procedure, in the product insert, was not followed at the point of specimen collection. The presence of glass in the collection tube would indicate that the dropper tip was removed when dispensing the transfer reagent into the collection tube. If the procedure, as indicated in the product insert, was followed, no glass would've been present in the tube. A review of the manufacturing process and components used indicates that no changes have been made which could cause this defect. A review of past complaints did not reveal a confirmed trend for this batch. All contents in the collection tube should be treated as pathogenically hazardous material, as instructed in the package insert "warning: pathogenic microorganisms, including hepatitis viruses and human immunodeficiency virus, may be present in clinical specimens. "standard precautions" and institutional guidelines should be followed in handling all items contaminated with blood and other body fluids. " the complaint is not confirmed for any product defect. Bd will continue to monitor this type of issue.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1119779-2012-00020
MDR Report Key2826318
Report Source05
Date Received2012-10-31
Date of Report2012-10-16
Date of Event2012-10-11
Date Mfgr Received2012-10-16
Date Added to Maude2012-11-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER HEALTH CARE PROFESSIONAL
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactGAIL CLAIBORNE
Manufacturer Street7 LOVETON CIR.
Manufacturer CitySPARKS MD 21152
Manufacturer CountryUS
Manufacturer Postal21152
Manufacturer Phone4103164054
Manufacturer G1BECTON DICKINSON INFUSION THERAPY
Manufacturer StreetPERIF. LUIS DONALDO COLOSIO #579
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameAFFIRM VPIII AMBIENT TEMPERATURE TRANSPORT
Product CodeJTX
Date Received2012-10-31
Catalog Number446255
Lot NumberUNK
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerBECTON DICKINSON INFUSION THERAPY SYSTEMS
Manufacturer AddressPERIF. LUIS DONALDO COLOSIO #579 NOGALES, SONORA 84048 MX 84048


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2012-10-31

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