BD BBL¿ VDRL ANTIGEN
Received Jul 25, 2024 · Event occurred Jun 25, 2024
Report 1025402-2024-00009 · MDR key 19824447
Device
Generic name
Antigens, Nontreponemal, All
Manufacturer
Lee Laboratories, Inc.Catalog number
240765
Lot number
3103242
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
INVESTIGATION SUMMARY: TO INVESTIGATE THE COMPLAINT ON CATALOG 240765, LOT 2227252, THE BUFFERED SALINE INCLUDED IN THE RETAINED KIT OF THE COMPLAINT LOT WAS TESTED FOR PH. A RETURN SAMPLE WAS NOT RECEIVED. THIS TESTING WAS PERFORMED USING A CALIBRATED PH METER WITH A THREE - POINT CALIBRATION THAT INCLUDED PH (B)(4) BUFFERS. AFTER CALIBRATION, THE RETAINED SAMPLE OF THE BUFFERED SALINE WAS TESTED, AND RESULTS WERE AS FOLLOWS: - RETAINED BOTTLE YIELDED 5.99 AT 24.6°C, WHICH IS WITHIN THE ACCEPTABLE RANGE OF 5.95 ¿ 6.05 AT 25°C. THE COMPLAINT WAS NOT CONFIRMED BASED ON THE PH RESULT OBTAINED. THE ELECTRODE USED WITH THE PH METER IS A PH / ATC ELECTRODE. THE INTERNAL TEST PROCEDURE FOR THIS PRODUCT REQUIRES THAT ALL CALIBRATION BUFFERS AND TEST SAMPLES ARE WARMED TO 25 ± 1°C PRIOR TO USE / TEST. POSSIBLE SOURCES OF ERROR FOR THE CUSTOMER INCLUDE PH SAMPLE WAS TESTED AT A TEMPERATURE SLIGHTLY DIFFERENT THAN THE RECOMMENDED TEMPERATURE FOR BUFFERED SALINE, OR CONTAMINATION OF THE BUFFERED SALINE SAMPLES. THE BATCH HISTORY RECORD FOR THE COMPLAINT LOT WAS REVIEWED AND FOUND SATISFACTORY; NO QUALITY NOTIFICATIONS WERE ISSUED FOR THIS LOT. COMPLAINTS FOR THE PRODUCT LINE WERE REVIEWED. THERE HAVE BEEN (B)(4) COMPLAINTS RECEIVED ON THE CATALOG NUMBER; THERE HAVE BEEN NO OTHER COMPLAINTS RECEIVED FOR THE COMPLAINT LOT; BD WILL CONTINUE TO MONITOR CLOSELY FOR TRENDS. NO CORRECTIVE ACTION IS NEEDED AT THIS TIME.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD BBL¿ VDRL ANTIGEN THE SALINE SOLUTION PH IS INCONSISTENT BETWEEN SEVERAL TESTING METHODS, PH TEST STRIPS, PH METER/PROBE, AND MULTISTICK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Description of Event or Problem
IT WAS REPORTED WHILE USING THE BD BBL¿ VDRL ANTIGEN THE SALINE SOLUTION PH IS INCONSISTENT BETWEEN SEVERAL TESTING METHODS, PH TEST STRIPS, PH METER/PROBE, AND MULTISTICK. NO HEALTH IMPACT OR CONSEQUENCE REPORTED.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.