BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE
Report
- Report Number
- 1917413-2022-00152
- Event Type
- Malfunction
- Date Received
- March 23, 2022
- Date of Event
- March 2, 2022
- Report Date
- June 6, 2022
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- Product Code
- JKA
- UDI-DI
- 50382903679602
- PMA / PMN Number
- K945952
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 1319265. MEDICAL DEVICE EXPIRATION DATE: 30-NOV-2022. DEVICE MANUFACTURE DATE: 15-NOV-2021. MEDICAL DEVICE LOT #: 1040986. MEDICAL DEVICE EXPIRATION DATE: 28-FEB-2022. DEVICE MANUFACTURE DATE: 09-FEB-2021. A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELDS HAVE BEEN UPDATED: D9: DEVICE AVAILABLE FOR EVAL? NO. D9: RETURNED TO MANUFACTURER ON: BLANK. H.6 INVESTIGATION SUMMARY: MATERIAL #: 367960; LOT/BATCH #: 1319265, 1040986. BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. THEREFORE, RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO ERRONEOUS RESULTS WERE OBSERVED. NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY (VALIDATION ATTACHED). ALL SAMPLES (RETAIN AND CONTROL LOTS) DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. ALL TUBES PERFORMED AS EXPECTED. BASED ON A REVIEW OF THE DEVICE HISTORY RECORD FOR THE INCIDENT LOT, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET. THERE WERE NO RELATED QUALITY ISSUES DURING MANUFACTURING OF THE PRODUCT. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR THE INDICATED FAILURE MODE ERRONEOUS RESULTS. BD WAS NOT ABLE TO IDENTIFY A ROOT CAUSE FOR THE INDICATED FAILURE MODE. FACTORS THAT MAY CONTRIBUTE TO ERRONEOUS RESULTS WERE EVALUATED THROUGH A CLINICAL STUDY TO VERIFY THE DESIGN OF THE DEVICE MET IT¿S INTENDED USE. THE RESULT OF THE STUDY SHOWED THAT THE DEVICE PERFORMED AS EXPECTED AND WE WERE UNABLE TO DETERMINE ANY EXTERNAL CONTRIBUTOR TO THIS REPORTED ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT 1 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE EACH FROM LOTS 1319265 AND 1040986 PRODUCED ERRONEOUS LEUKEMIA READINGS ON THE PLASMA. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THAT SHE RECEIVED DISCREPANT RESULTS WITH TWO TUBES ON FRIDAY, ONE ON MONDAY, AND ONE YESTERDAY EVENING. SHE STATES THAT THEY ARE GETTING HIGHER READINGS ON PLASMA ON THE LEUKEMIA READING. SHE STATES THAT THE LAB THEY'RE GETTING THE TUBES FROM ARE WAITING TO CENTRIFUGE WHEN IT CLOTS" "CUSTOMER EXPLAINED THEY ARE VALIDATING THE PST TUBE AND RUNNING AN SST TUBE AND PST TUBE ON THE ROCHE PRO C503 AND MOST OF THE PST TUBES ARE COMING UP WITH HIGH LIPEMIA LEVELS VS THE SST WITH NO LIPEMIA LEVEL. THE TUBES ARE DRAWN, CENTRIFUGED AND TRANSPORTED TO THE LAB FOR TESTING. SHE STATES THAT THE PLASMA OF PST TUBES APPEARS CLEAR."
IT WAS REPORTED THAT 1 BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE EACH FROM LOTS 1319265 AND 1040986 PRODUCED ERRONEOUS LEUKEMIA READINGS ON THE PLASMA. THERE WAS NO INDICATION OF CONFIRMATORY TESTING, OR THAT RESULTS WERE REPORTED TO CLINICIANS. THERE WAS ALSO NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER STATES THAT SHE RECEIVED DISCREPANT RESULTS WITH TWO TUBES ON FRIDAY, ONE ON MONDAY, AND ONE YESTERDAY EVENING. SHE STATES THAT THEY ARE GETTING HIGHER READINGS ON PLASMA ON THE LEUKEMIA READING. SHE STATES THAT THE LAB THEY'RE GETTING THE TUBES FROM ARE WAITING TO CENTRIFUGE WHEN IT CLOTS" "CUSTOMER EXPLAINED THEY ARE VALIDATING THE PST TUBE AND RUNNING AN SST TUBE AND PST TUBE ON THE ROCHE PRO C503 AND MOST OF THE PST TUBES ARE COMING UP WITH HIGH LIPEMIA LEVELS VS THE SST WITH NO LIPEMIA LEVEL. THE TUBES ARE DRAWN, CENTRIFUGED AND TRANSPORTED TO THE LAB FOR TESTING. SHE STATES THAT THE PLASMA OF PST TUBES APPEARS CLEAR."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1021477 | BD VACUTAINER® PST¿ GEL AND LITHIUM HEPARINN (LH) BLOOD COLLECTION TUBE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 367960 | SEE SECTION H10 | 50382903679602 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |