BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR
Report
- Report Number
- 3003916417-2020-00162
- Event Type
- Malfunction
- Date Received
- June 8, 2020
- Date of Event
- May 18, 2020
- Report Date
- July 22, 2020
- Manufacturer
- BECTON DICKINSON IND. CIRURGICAS LTDA
- Product Code
- JKA
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE INFORMATION IN B.5 WAS UPDATED WITH A CORRECT # OF OCCURRENCES: B.5. DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT FIBRIN FORMATION IS OCCURRING WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THIS OCCURRED ON 250 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: FIBRIN FORMATION IN THE 5ML GEL TUBE. CUSTOMER DISCARDS ALL FIBRIN TUBES. CUSTOMER EXPERIENCED THIS ISSUE IN THE PAST AND NOW AGAIN WITH THIS NEW BATCH.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/10/2020. H.6. INVESTIGATION: BD HAD RECEIVED SAMPLES FROM THE CUSTOMER FOR EVALUATION. FIVE PHOTOS WERE RECEIVED FOR EVALUATION. THE PHOTOS SHOW RED CELL HANG UP AND FIBRIN. 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 NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. ALL ANALYTES DEMONSTRATED CLINICALLY ACCEPTABLE PERFORMANCE FOR ALL VISUAL OBSERVATIONS EVALUATED. IN ADDITION, RESULTS FOR CELL SENSITIVE ANALYTES DEMONSTRATED CLINICAL EQUIVALENCE AND HEMOLYSIS INDEX SHOWED NO STATISTICALLY SIGNIFICANT DIFFERENCE BETWEEN THE EVALUATION AND CONTROL TUBES. ALL LOTS ARE WITHIN THE SAME MANUFACTURING TIMEFRAME. SST¿ TUBES SHOULD BE FILLED TO STATED DRAW VOLUME AND MIXED BY AT LEAST 5 COMPLETE AND GENTLE INVERSIONS. MIXING FACILITATES DISPERSION OF THE SILICA INTO THE BLOOD, ASSISTING THE CLOTTING PROCESS. THE MINIMUM CLOTTING TIME FOR THE BD SST¿ TUBE (RECOMMENDED 30 MINUTE) IS BASED UPON AN INTACT CLOTTING PROCESS. INSUFFICIENT CLOTTING (SHORT CLOTTING TIME) CAN RESULT IN THE FORMATION OF FIBRIN. THIS FIBRIN FORMATION MAY INTERFERE WITH BARRIER FORMATION. COMPLETE AND ADEQUATE BARRIER FORMATION IS DEPENDENT ON CENTRIFUGATION TIME, TEMPERATURE CONDITIONS AND G-FORCE. POST CENTRIFUGATION: THE SPECIMEN IN THE ORIGINAL TUBE SHOULD BE CENTRIFUGED ONCE. TUBES SHOULD NOT BE RE-CENTRIFUGED ONCE THE BARRIER IS FORMED. A POTENTIAL FOR INACCURATE TEST RESULTS IS POSSIBLE. ANALYTES FROM CELLULAR LEAKAGE/EXCHANGE, ACCENTUATED BY CLOT RETRACTION, WILL THEN BE CENTRIFUGED INTO THE SERUM BEING USED FOR TESTING. IF RE-CENTRIFUGATION IS REQUIRED FOR IMPROVED SERUM QUALITY, THEN ASPIRATE SERUM INTO A PROPERLY LABELED CLEAN TUBE. TO ASSURE HIGH QUALITY SPECIMENS SEVERAL FACTORS ARE KEY. INCLUDED, BUT NOT LIMITED TO THIS ARE: PROPER PHLEBOTOMY TECHNIQUE TO MINIMIZE HEMOLYSIS AND PLATELET ACTIVATION, PROPER TUBE FILL VOLUME TO ASSURE THE PROPER BLOOD-TO-ADDITIVE RATION, GENTLE AND THOROUGH MIXING, PROPER CENTRIFUGATION CONDITIONS-G FORCE AND TIME, AND STORAGE CONDITIONS. WHEN USING A WINGED BLOOD COLLECTION SET FOR VENIPUNCTURE, A DISCARD TUBE MUST BE USED TO FILL THE BLOOD COLLECTION SET TUBING¿S ¿DEAD SPACE¿ WITH BLOOD. THE DISCARD DOES NOT NEED TO BE FILLED COMPLETELY. THE DISCARD TUBE SHOULD BE A NON-ADDITIVE OR COAGULATION TUBE. ADHERENCE TO THE RECOMMENDED SPECIMEN HANDLING AND PROCESSING STEPS WILL FACILITATE ACCEPTABLE SPECIMEN QUALITY AND OVERALL PERFORMANCE FOR RELIABLE ANALYTICAL OUTCOMES. EVALUATION OF LABORATORY INSTRUMENTATION REGARDING REPRODUCIBILITY/REPEATABILITY MAY BE OF VALUE. IN ADDITION, DRUGS/MEDICATIONS CAN CHANGE THE DENSITY OF A BLOOD SPECIMEN, FURTHER CONTRIBUTING TO THIS REPORTED CONDITION. A REVIEW OF SPECIMEN HANDLING PARAMETERS SHOULD BE REVIEWED FOR THIS TUBE TYPE. BASED ON THE DHR REVIEW AND THE INVESTIGATION PERFORMED, BD WAS UNABLE TO REPLICATE THE CUSTOMER ISSUE. HOWEVER, BASED ON THE REVIEW OF THE PHOTOS PROVIDED, THIS COMPLAINT HAS BEEN CONFIRMED. 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. H3 OTHER TEXT : SEE H.10.
IT WAS REPORTED THAT FIBRIN FORMATION IS OCCURRING WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THIS OCCURRED ON 250 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: FIBRIN FORMATION IN THE 5ML GEL TUBE. CUSTOMER DISCARDS ALL FIBRIN TUBES. CUSTOMER EXPERIENCED THIS ISSUE IN THE PAST AND NOW AGAIN WITH THIS NEW BATCH.
IT WAS REPORTED THAT FIBRIN FORMATION IS OCCURRING WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THIS OCCURRED ON 250 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: FIBRIN FORMATION IN THE 5ML GEL TUBE. CUSTOMER DISCARDS ALL FIBRIN TUBES. CUSTOMER EXPERIENCED THIS ISSUE IN THE PAST AND NOW AGAIN WITH THIS NEW BATCH.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT FIBRIN FORMATION IS OCCURRING WITH A BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR. THIS OCCURRED ON 10000 SEPARATE OCCASIONS DURING USE, HOWEVER, THE PATIENT INFORMATION IS UNKNOWN. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM SPANISH TO ENGLISH: FIBRIN FORMATION IN THE 5ML GEL TUBE. CUSTOMER DISCARDS ALL FIBRIN TUBES. CUSTOMER EXPERIENCED THIS ISSUE IN THE PAST AND NOW AGAIN WITH THIS NEW BATCH.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 590773 | BD TUBE SST PLH 13X100 5.0 PLBL GOLD BR | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON DICKINSON IND. CIRURGICAS LTDA | 9304694 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |