BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM
Received Jan 11, 2018 · Event occurred Dec 18, 2017
Report 9610847-2017-00240 · MDR key 7183459
Device
Generic name
Direct Testing/serology
Manufacturer
Bd Infusion Therapy Systems Inc. S.a. De C.v.Catalog number
446255
Lot number
7243600
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Needle Stick/Puncture
- Needle Stick/Puncture
Narrative
Additional Manufacturer Narrative
INVESTIGATION: INVESTIGATION SUMMARY: BD MOLECULAR QUALITY PREVIOUSLY INVESTIGATED AN END USER, AFFIRM ATTS GLASS USER INJURY (FINGER PUNCTURE) DURING DISPENSE OF SPECIMEN AT AN AFFIRM TESTING FACILITY. IT WAS CONFIRMED THAT THE END USER FOUND GLASS IN THE SPECIMEN COLLECTION TUBE. QUALITY INVESTIGATION REQUIRED REVIEW OF THE AFFIRM ATTS PACKAGE INSERT AND AFFIRM COLLECTION POSTER. PER REVIEW OF THE AFFIRM PACKAGE INSERT & COLLECTION POSTER, IT WAS DETERMINED THAT THE AFFIRM COLLECTION SITE WAS NOT FOLLOWING THE AFFIRM ATTS PACKAGE INSERT OR AFFIRM COLLECTION POSTER INSTRUCTIONS. THE COLLECTION SITE WAS CRUSHING THE ATTS GLASS AMPULE (AS INSTRUCTED), OPENING THE ATTS CAP AND POURING THE GLASS INTO THE AFFIRM SAMPLE COLLECTION TUBE (NOT INSTRUCTED). THE AFFIRM PACKAGE INSERT AND AFFIRM COLLECTION POSTER DOES NOT INSTRUCT COLLECTION SITES TO OPEN THE ATTS VIAL AND POUR THE GLASS INTO THE COLLECTION TUBE. BD HAS COMPLETED AN UPDATE TO THE AFFIRM COLLECTION POSTER TO PROVIDE FURTHER CLARIFICATION ON THE INSTRUCTIONS OF USE WITH AFFIRM ATTS. BD MOLECULAR QUALITY WILL CONTINUE TO CLOSELY MONITOR FOR TRENDS ASSOCIATED WITH AFFIRM ATTS GLASS INJURY. INVESTIGATION CONCLUSION: NOT CONFIRMED. CUSTOMER EDUCATION ISSUE. ROOT CAUSE DESCRIPTION: OFF-LABEL USE.
Description of Event or Problem
IT WAS REPORTED THAT A TECHNICIAN EXPERIENCED A PUNCTURE FROM GLASS FROM A BD AFFIRM¿ VPIII AMBIENT TEMPERATURE TRANSPORT SYSTEM DURING THE FILTERING STEP OF THE PROCESS.