BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES

Report

Report Number: 9617032-2019-01310
Event Type: Malfunction
Date Received: November 21, 2019
Date of Event: October 31, 2019
Report Date: May 8, 2020
Manufacturer: BECTON, DICKINSON AND COMPANY (BD)
Product Code: JKA
UDI-DI: 50382903666435
PMA / PMN Number: BK050036
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: PA, US
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH ADDITIONAL/CORRECTED INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® K2 EDTA (K2E) PLUS BLOOD COLLECTION TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (1 OF 2 COMPLAINTS) IT IS REPORTED CUSTOMER EXPERIENCED CLOTTING BUT IS UNSURE OF SPECIFIC LOT. ADDITIONAL INFORMATION RECEIVED 2019-12-04 BY CUSTOMER: IS THE SPECIFIC LOT WITNESSED AS CLOTTING SAMPLES KNOWN?: (8155920; 8204622; 8228872; 8295716; 9148946) . WAS TUBE FILLED TO THE PROPER DRAW VOLUME? (YES). HOW MANY TIMES WAS THE TUBE INVERTED? (8 TO 10 TIMES). WAS THE TUBE STORED IN THE REFRIGERATOR? (TUBES WERE STORED AT AMBIENT TEMPERATURE PRIOR TO SAMPLE COLLECTION. FINAL ALIQUOTS WERE STORED AT -80°C). WHAT IS THE TIME FROM COLLECTION TO ANALYSIS? (WITHIN 30 MINUTES OF COLLECTION, BLOOD SAMPLES WERE CENTRIFUGED FOR 15 MINUTES AT 1300 X G , TRANSFERRED TO CRYOVIALS, AND STORED AT -80°C FOR ~3 MONTHS.)" "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE POSSIBLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: MEDICAL DEVICE LOT #: 8155920, MEDICAL DEVICE EXPIRATION DATE: 2019-06-30, DEVICE MANUFACTURE DATE: 2018-06-04, MEDICAL DEVICE LOT #: 8204622, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2018-07-23, MEDICAL DEVICE LOT #: 8228872, MEDICAL DEVICE EXPIRATION DATE: 2019-08-31, DEVICE MANUFACTURE DATE: 2018-08-16, MEDICAL DEVICE LOT #: 8295716, MEDICAL DEVICE EXPIRATION DATE: 2019-10-31, DEVICE MANUFACTURE DATE: 2018-10-22, MEDICAL DEVICE LOT #: 9148946, MEDICAL DEVICE EXPIRATION DATE: 2020-06-30 AND DEVICE MANUFACTURE DATE: 2019-05-28.

Additional Manufacturer Narrative · 0

THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: "MULTIPLE LOT NUMBERS: THERE WERE MULTIPLE LOT NUMBERS REPORTED TO BE INVOLVED. THE INFORMATION FOR EACH LOT NUMBER IS AS FOLLOWS: D.4. MEDICAL DEVICE LOT #: 8155920. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-06-30. H.4. DEVICE MANUFACTURE DATE: 2018-06-04. D.4. MEDICAL DEVICE LOT #: 8204622. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. H.4. DEVICE MANUFACTURE DATE: 2018-07-23. D.4. MEDICAL DEVICE LOT #: 8228872. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-08-31. H.4. DEVICE MANUFACTURE DATE: 2018-08-16. D.4. MEDICAL DEVICE LOT #: 8295716. D.4. MEDICAL DEVICE EXPIRATION DATE: 2019-10-31. H.4. DEVICE MANUFACTURE DATE: 2018-10-22. D.4. MEDICAL DEVICE LOT #: 9148946. D.4. MEDICAL DEVICE EXPIRATION DATE: 2020-06-30. H.4. DEVICE MANUFACTURE DATE: 2019-05-28. " H3 OTHER TEXT : SEE H.10.

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR ALL THE POSSIBLE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT.

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION SUMMARY : BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS COMPLETED FOR THE INCIDENT LOT AND, BASED ON THIS REVIEW, ALL PRODUCT SPECIFICATIONS AND REQUIREMENTS FOR LOT RELEASE WERE MET; THERE WERE NO RELATED QUALITY NON-CONFORMANCES DURING MANUFACTURING OF THE PRODUCT. H3 OTHER TEXT : SEE SECTION H.10.