BD MICROTAINER® TUBES WITH K2E (K2EDTA)
Report
- Report Number
- 2618282-2019-00210
- Event Type
- Malfunction
- Date Received
- June 27, 2019
- Date of Event
- May 16, 2019
- Report Date
- July 31, 2019
- Manufacturer
- BD CARIBE LTD.
- Product Code
- JKA
- UDI-DI
- 50382903649025
- PMA / PMN Number
- K991702
- Removal / Correction Number
- PAS-19-1526
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
INVESTIGATION: INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION. RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, THE ISSUE RELATING TO CLOTTING WAS OBSERVED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA#896640 AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION/TESTING OF THE RETAIN SAMPLES, THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA#896640 AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA#896640 WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQURIED: THIS COMPLAINT IS ASSOCIATED TO FIELD ACTION # 2243072-05/09/2019-007-R. 1. RECALL SUMMARY. BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR MULTIPLE LOTS OF THE BD MICROTAINER® TUBE W/ BD MICROGARDTM CLOSURE, K2EDTA ADDITIVE, BASED ON CONFIRMED COMPLAINTS OF REDUCED WITHIN THE TUBE RESERVOIR. 2. PRODUCT AND SCOPE. BD MICROTAINER® TUBE W/ BD MICROGARDTM CLOSURE, K2EDTA ADDITIVE, CATALOG# 365974, ARE USED TO COLLECT, TRANSPORT AND STORE SKIN PUNCTURE BLOOD SPECIMENS FOR HEMATOLOGY TESTS, OR FOR TESTS UTILIZING SERUM OR HEPARINIZED PLASMA. 3. DESCRIPTION OF ISSUE. THE REFERENCED LOTS HAVE BEEN CONFIRMED TO HAVE REDUCED OR NO ADDITIVE WITHIN THE TUBE RESERVOIR. BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM. 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE. PER 806 # 2243072-05/09/2019-007-R DATED JUNE 5, 2019 THERE WERE A TOTAL OF 2 COMPLAINTS AND 2 MDRS WITHIN SCOPE AT THE TIME THE FIELD ACTION WAS MADE. 5. HHE SUMMARY. THIS ISSUE MAY DEVELOP VISIBLE CLOTS WITHIN THE TUBE SAMPLES OR MICRO CLOTS THAT ARE NOT EASILY DETECTED DURING VISUAL INSPECTION OF THE TUBES. AS A RESULT, THIS MAY LEAD TO RECOLLECTION OF SAMPLES OR, RETESTING OF PATIENTS, RESULTING IN DELAYED REPORTING OF TEST RESULTS AND PATIENT TREATMENT. ADDITIONALLY, IF A MICRO CLOT IS UNDETECTED, IT MAY CONTRIBUTE TO INACCURATE CELL COUNTS INCLUDING PLATELET, AND HEMOGLOBIN LEVELS THAT COULD POTENTIALLY PRODUCE ERRONEOUS RESULTS THAT IMPACT PATIENT TREATMENT. THIS MAY LEAD TO MODERATE HEALTH HAZARD TO PATIENTS. 6. INVESTIGATION SUMMARY: EVALUATION OF COMPLAINT SAMPLES CONFIRMED THAT ADDITIVE WAS NOT VISUALLY PRESENT INSIDE THE TUBES. SUBSEQUENTLY, RETENTION LOT SAMPLES FROM PRIOR AND POST MANUFACTURE OF THE COMPLAINT LOT WERE TESTED AND CONFIRMED THE DEFECT WAS LIMITED TO (B)(4) LOTS MANUFACTURED FROM JANUARY 2019 TO FEBRUARY 2019. BD PAS HAS INITIATED CAPA 896640 TO FURTHER INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. 7.RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z#. BD RECALL # PAS-19-1526.
IT WAS REPORTED THAT THE BD MICROTAINER® TUBE WITH K2E (K2EDTA) CLOTTED AFTER USE DESPITE PROPER INVERSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD 2 PATIENT SAMPLES THAT HAVE CLOTTED IN THE LAST 2 DAYS AND NOT SURE WHY BECAUSE BOTH PATIENTS BLED VERY WELL FROM THEIR FINGER AND THE SAMPLE WAS INVERTED PROPERLY."
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
INVESTIGATION SUMMARY: BD RECEIVED SAMPLES FROM THE CUSTOMER FACILITY FOR INVESTIGATION. THE SAMPLES WERE EVALUATED AND THE CUSTOMER'S INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS OBSERVED. ADDITIONALLY, RETENTION SAMPLES WERE SELECTED FROM BD INVENTORY FOR EVALUATION/TESTING AND UPON COMPLETION, THE ISSUE RELATING TO CLOTTING WAS OBSERVED. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH CAPA# (B)(4) AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. INVESTIGATION CONCLUSION: BASED ON EVALUATION OF THE CUSTOMER SAMPLES, THE CUSTOMER¿S INDICATED FAILURE MODE FOR CLOTTING WITH THE INCIDENT LOT WAS OBSERVED. EVALUATION/TESTING OF THE RETAIN SAMPLES WAS ALSO CONDUCTED AND CLOTTING WAS OBSERVED. FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH CAPA# (B)(4) AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ROOT CAUSE DESCRIPTION: CAPA# (B)(4) WAS CONDUCTED TO DOCUMENT FURTHER INVESTIGATION AND ROOT CAUSE ANALYSIS RELATING TO THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. RATIONALE: BASED ON AN ASSESSMENT OF SEVERITY AND FREQUENCY, IT WAS DETERMINED THAT A CAPA IS REQUIRED AT THIS TIME IN ORDER TO DETERMINE THE ROOT CAUSE ASSOCIATED WITH THIS ISSUE. THE INVESTIGATION HAS IDENTIFIED POTENTIAL ROOT CAUSE(S) FOR THIS ISSUE AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED.
IT WAS REPORTED THAT THE BD MICROTAINER® TUBE WITH K2E (K2EDTA) CLOTTED AFTER USE DESPITE PROPER INVERSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD 2 PATIENT SAMPLES THAT HAVE CLOTTED IN THE LAST 2 DAYS AND NOT SURE WHY BECAUSE BOTH PATIENTS BLED VERY WELL FROM THEIR FINGER AND THE SAMPLE WAS INVERTED PROPERLY."
IT WAS REPORTED THAT THE BD MICROTAINER® TUBE WITH K2E (K2EDTA) CLOTTED AFTER USE DESPITE PROPER INVERSION. THIS COMPLAINT WAS CREATED TO CAPTURE THE 1ST OF 4 RELATED INCIDENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WE HAVE HAD 2 PATIENT SAMPLES THAT HAVE CLOTTED IN THE LAST 2 DAYS AND NOT SURE WHY BECAUSE BOTH PATIENTS BLED VERY WELL FROM THEIR FINGER AND THE SAMPLE WAS INVERTED PROPERLY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 535750 | BD MICROTAINER® TUBES WITH K2E (K2EDTA) | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BD CARIBE LTD. | 9017593 | 50382903649025 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |