BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES
Report
- Report Number
- 9617032-2023-01402
- Event Type
- Malfunction
- Date Received
- October 10, 2023
- Date of Event
- September 15, 2023
- Report Date
- February 2, 2024
- Manufacturer
- BECTON, DICKINSON AND COMPANY (BD)
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SW
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
B.3. DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
H.6. INVESTIGATION SUMMARY: RETENTION SAMPLES OF THE INCIDENT LOT WERE SELECTED FROM BD INVENTORY FOR EVALUATION AND UPON COMPLETION, NO ISSUES RELATING TO HEMOLYSIS OR ERRONEOUS RESULTS WERE OBSERVED. COMPLAINTS FOR SAMPLE QUALITY ARE UNDER STATISTICAL CONTROL FOR THE MONTH OF (B)(6) 2023. AT THIS TIME, FURTHER TESTING FOR HEMOLYSIS IS NOT INDICATED. CLINICAL TESTING FOR ERRONEOUS RESULTS (POTASSIUM) WAS PERFORMED ON LOT 3163205: NO DIFFICULTIES WERE ENCOUNTERED DURING BLOOD COLLECTION AND ALL TUBES APPEARED TO EXHIBIT PROPER FILL. BD WAS UNABLE TO DUPLICATE OR CONFIRM THE CUSTOMER¿S INDICATED FAILURE (ERRONEOUS RESULTS-POTASSIUM) BECAUSE THE DEFECT WAS NOT EVIDENT IN THE TESTING OF THE COMPLAINT LOT SAMPLES. ALL VISUAL OBSERVATIONS OF BOTH RETAIN AND CONTROL SAMPLES TESTED DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE. REPLICATES OF BOTH RETAIN AND CONTROL SAMPLES TESTED WERE ACCEPTABLE IN TERMS OF BOTH PRECISION AND ACCURACY. 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 HEMOLYSIS AND 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR THE ADDITIONAL LOT NUMBER IS AS FOLLOWS.: D4. MEDICAL DEVICE LOT #: UNKNOWN. D4. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. H4. DEVICE MANUFACTURE DATE: UNKNOWN. H.6. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FOR EVALUATION. ADDITIONALLY, BD WAS UNABLE TO DETERMINE THE SPECIFIC LOT NUMBER ASSOCIATED WITH THIS COMPLAINT; THEREFORE, A REVIEW OF THE DEVICE HISTORY RECORD COULD NOT BE CONDUCTED. THIS COMPLAINT IS UNABLE TO BE CONFIRMED FOR ERRONEOUS RESULTS OR HEMOLYSIS. IF ADDITIONAL INFORMATION IS MADE AVAILABLE, THIS COMPLAINT WILL BE REOPENED TO ASSESS THE LEVEL OF INVESTIGATION NEEDED. SAMPLE QUALITY COMPLAINTS FOR THE MONTH OF SEPTEMBER 2023 WERE UNDER STATISTICAL CONTROL. 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. BD QUALITY WILL CONTINUE TO MONITOR SAMPLE QUALITY COMPLAINTS.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THEY FOUND HEMOLYSIS AND ERRONEOUS RESULTS. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: CUSTOMER HIGHLIGHTED THAT THEY HAD A INCREASE OF HEMOLYSIS RATE, POTASSIUM . CUSTOMER CLAIMS THAT THEY HAVE HAD A INCREASED RATE OF HEMOLYSIS IN PST II TUBES. ONLY INFORMATION WE HAVE IS THAT FROM THIS WARD DURING WEEK 36 THEY GOT FROM 2% > 10% POTASSIUM. IT´S ONLY FROM 1 WARD THAT HIGHLIGHTED AN INCREASED HEMOLYSIS RATE. NO OTHER INFORMATION IS GIVEN, A MEETING WITH THE CUSTOMER WILL BE 09/20/2023 AND MORE INFORMATION WILL BE SHARED. UNKNOWN ANY IMPACT ON PATIENTS OR STAFF.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THEY FOUND HEMOLYSIS AND ERRONEOUS RESULTS. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: CUSTOMER HIGHLIGHTED THAT THEY HAD A INCREASE OF HEMOLYSIS RATE, POTASSIUM . CUSTOMER CLAIMS THAT THEY HAVE HAD A INCREASED RATE OF HEMOLYSIS IN PST II TUBES. ONLY INFORMATION WE HAVE IS THAT FROM THIS WARD DURING WEEK 36 THEY GOT FROM 2% > 10% POTASSIUM. IT´S ONLY FROM 1 WARD THAT HIGHLIGHTED AN INCREASED HEMOLYSIS RATE. NO OTHER INFORMATION IS GIVEN, A MEETING WITH THE CUSTOMER WILL BE (B)(6) 2023 AND MORE INFORMATION WILL BE SHARED. UNKNOWN ANY IMPACT ON PATIENTS OR STAFF.
IT WAS REPORTED THAT WHILE USING BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES THEY FOUND HEMOLYSIS AND ERRONEOUS RESULTS. THE FOLLOWING WAS REPORTED BY THE INITIAL REPORTER: CUSTOMER HIGHLIGHTED THAT THEY HAD A INCREASE OF HEMOLYSIS RATE, POTASSIUM . CUSTOMER CLAIMS THAT THEY HAVE HAD A INCREASED RATE OF HEMOLYSIS IN PST II TUBES. ONLY INFORMATION WE HAVE IS THAT FROM THIS WARD DURING WEEK 36 THEY GOT FROM 2% > 10% POTASSIUM. IT´S ONLY FROM 1 WARD THAT HIGHLIGHTED AN INCREASED HEMOLYSIS RATE. NO OTHER INFORMATION IS GIVEN, A MEETING WITH THE CUSTOMER WILL BE (B)(6) 2023 AND MORE INFORMATION WILL BE SHARED. UNKNOWN ANY IMPACT ON PATIENTS OR STAFF.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2163915 | BD VACUTAINER® LH PST¿ II PLUS BLOOD COLLECTION TUBES | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON AND COMPANY (BD) | SEE H. 10 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |