UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES
Report
- Report Number
- 2243072-2025-01250
- Event Type
- Malfunction
- Date Received
- October 15, 2025
- Date of Event
- September 11, 2025
- Report Date
- December 29, 2025
- Manufacturer
- BECTON DICKINSON & CO (FRANKLIN LAKES)
- Product Code
- JKA
- PMA / PMN Number
- UNKNOWN
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE FOLLOWING FIELDS WERE UPDATED BASED ON CORRECTED INFORMATION: B5. DESCRIBE EVENT OR PROBLEM: A CUSTOMER REPORTED BASED ON A LITERATURE REVIEW, UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES CAN GIVE FALSELY LOW GLUCOSE READINGS IF TUBES ARE NOT STORED ON ICE AND PROCESSED WITHIN 2.5 HOURS OF COLLECTION. THIS FINDING IS BASED ON PEER REVIEWED UK LITERATURE REPORTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED. D1. MEDICAL DEVICE BRAND NAME: UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES INVESTIGATION SUMMARY: THE (B)(4), SUBMITTED IN SEPTEMBER 2025, WAS INVESTIGATED. ALTHOUGH NO SPECIFIC MATERIAL OR LOT NUMBER WAS PROVIDED, THE COMPLAINT REFERENCED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES. AS PART OF BD¿S INTERNAL PROCEDURES, THE TEAM ASSESSED WHETHER THE EVENT REQUIRED UPDATES TO THE INSTRUCTIONS FOR USE (IFU) OR REPORTING TO HEALTH AUTHORITIES. NO IMMEDIATE CHANGES WERE IDENTIFIED, AND REPORTING REQUIREMENTS WERE EVALUATED IN ACCORDANCE WITH REGULATORY OBLIGATIONS. THE INVESTIGATION CONFIRMED THAT THE BD VACUTAINER® FLUORIDE BLOOD COLLECTION TUBE AND ITS LABELING COMPLY WITH ALL APPLICABLE REGULATORY AND QUALITY REQUIREMENTS, INCLUDING CE MARKING UNDER THE EU IN VITRO DIAGNOSTIC REGULATION (EU 2017/746), CLASS A (STERILE), RULE 5(C) AND U.S. FDA CLEARANCE UNDER K231237. BD WILL CONTINUE TO EVALUATE WHETHER THIS EVENT NECESSITATES AN IFU UPDATE AND/OR REPORTING TO HEALTH AUTHORITIES. IF REPORTING IS REQUIRED, APPROPRIATE NOTIFICATIONS WILL BE MADE. RELATED COMPLAINTS WILL BE TRACKED AND TRENDED AS PART OF ONGOING MONITORING.
UNKNOWN MANUFACTURER: A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN D4. UNIQUE IDENTIFIER (UDI) #: UNKNOWN H4. DEVICE MANUFACTURE DATE: UNKNOWN A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
A CUSTOMER REPORTED BASED ON A LITERATURE REVIEW, UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES CAN GIVE FALSELY LOW GLUCOSE READINGS IF TUBES ARE NOT STORED ON ICE AND PROCESSED WITHIN 2.5 HOURS OF COLLECTION. THIS FINDING IS BASED ON PEER REVIEWED UK LITERATURE REPORTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
IT WAS REPORTED BASED ON A LITERATURE REVIEW; AN UNSPECIFIED BD VACUTAINER® GLUCOSE TUBE CAN GIVE FALSELY LOW GLUCOSE READINGS IF TUBES ARE NOT STORED ON ICE AND PROCESSED WITHIN 2.5 HOURS OF COLLECTION. THIS FINDING IS BASED ON PEER REVIEWED UK LITERATURE REPORTS. THERE WAS NO OTHER HEALTH IMPACT OR CONSEQUENCES REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 10828 | UNSPECIFIED BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE TUBES | TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION | JKA | BECTON DICKINSON & CO (FRANKLIN LAKES) | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |