BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 100 MG/20 MG
Report
- Report Number
- 1917413-2018-04055
- Event Type
- Malfunction
- Date Received
- December 28, 2018
- Date of Event
- December 13, 2018
- Report Date
- July 5, 2019
- Manufacturer
- BECTON, DICKINSON & CO.
- Product Code
- JKA
- UDI-DI
- 50382903670012
- PMA / PMN Number
- K901449
- Removal / Correction Number
- PAS-19-1461
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQUIRED: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-05/09/2019-008-R 1. RECALL SUMMARY BD IS CONDUCTING A VOLUNTARY MEDICAL DEVICE RECALL FOR THE BD VACUTAINER® FLUORIDE TUBES FOR BLOOD ALCOHOL DETERMINATIONS, CATALOG# 367001, LOT #8187663. THE RECALLED LOT HAS BEEN CONFIRMED TO HAVE NO ADDITIVE WITHIN THE TUBE. 2. PRODUCT AND SCOPE BD VACUTAINER® FLUORIDE TUBES FOR BLOOD ALCOHOL DETERMINATIONS. 3. DESCRIPTION OF ISSUE THE RECALLED LOT HAS BEEN CONFIRMED TO HAVE NO ADDITIVE WITHIN THE TUBE (SEE INVESTIGATION SUMMARY BELOW FOR SCOPING DETAILS). BD PAS IDENTIFIED THIS ISSUE THRU THE BD COMPLAINT INVESTIGATION SYSTEM. 4. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE PER 806 # 2243072-05/09/2019-008-R DATED (B)(6) 2019, THERE WERE A TOTAL OF 2 COMPLAINTS AND 2 MDRS WITHIN SCOPE: COMPLAINT: (B)(4) / MDR: 1917413-2018-04055 COMPLAINT: (B)(4) / MDR: 1917413-2018-04112 5. HHE SUMMARY THE DEFECT FOR THIS PRODUCT IS RELATIVELY VISIBLE, AND FOLLOWING CLSI RECOMMENDED CLINICAL PRACTICE, THE PRODUCT WOULD BE INSPECTED PRIOR TO USE AND NOT BE USED FOR TESTING. HOWEVER, IF THE DEFECTIVE PRODUCT WAS USED FOR TESTING IT IS CRUCIAL TO BE ABLE TO STATE WITH CONFIDENCE THAT A REPORTED AMOUNT OF ALCOHOL WAS, IN FACT, PRESENT. IF COLLECTED AND TESTED, THE TUBES LACKING THE ADDITIVES, WILL ESSENTIALLY YIELD A CLOTTED SAMPLE THAT WOULD BE REJECTED. IF THESE SAMPLES DID GET TESTED, LITERATURE STATES THAT SAMPLES WITHOUT THIS PRESERVATIVE HAVE YIELDED RELIABLE RESULTS FOR SAMPLES STORED AT ROOM TEMPERATURE (25OC) FOR 2 DAYS. THE PATIENT WOULD BE TREATED BASED ON THEIR CLINICAL PICTURE AS PER CLINICAL PRACTICE, REGARDLESS OF THE RESULT WHEN THE PATIENT'S CLINICAL STATUS IS ASSESSED. IN CASE THE CLOTTED SAMPLES WERE NOT REJECTED AND SERUM WAS INADVERTENTLY TESTED AFTER 2 DAYS, THERE MAY BE A REMOTE CHANCE OF ERRONEOUS RESULTS, HOWEVER TREATMENT IS NOT DEPENDENT ON THE RESULT. ALSO, THE CHANCE OF BLOOD ALCOHOL TESTING AFTER TWO DAYS IS UNLIKELY. SINCE ALCOHOL RESULTS FROM SERUM SAMPLES LACK FORENSIC VALUE, CLOTTED SAMPLES WOULD NOT BE SUITABLE FOR TESTING DUE TO THE ABSENCE OF A RELIABLE CONVERSION FACTOR FROM SERUM TO WHOLE BLOOD. THEREFORE THE RESULTS COULD NOT BE USED FOR LEGAL REASONS. THE OVERALL HEALTH RISK ASSOCIATED WITH THIS DEFECT IS CONSIDERED VERY LOW. 6. INVESTIGATION SUMMARY DHR REVIEW WAS PERFORMED AND FOUND NO ISSUES WITH THE PRODUCT IN SCOPE. EVALUATION OF 200 TOTAL COMPLAINT SAMPLES VISUALLY CONFIRMED ¿INCORRECT ADDITIVE QUANTITY¿. ADDITIONALLY, 100 RETAIN SAMPLES FROM LOT 8187663 WERE EVALUATED, THESE SAMPLES DID NOT INDICATE ¿INCORRECT ADDITIVE QUANTITY¿. ALL PROCESS AND FINAL INSPECTIONS COMPLY WITH SPECIFICATION REQUIREMENTS. SUBSEQUENTLY, VIDEO FOOTAGE AT THE FILLING OPERATION WAS REVIEWED, IT WAS CONFIRMED THAT A 300 TUBE BATCH TRAY WAS INADVERTENTLY REMOVED FROM THE LINE PRIOR TO THE POWDER FILLING DISPENSING OPERATION, THIS UNFILLED TRAY WAS THEN PLACED ONTO A PALLET WITH POWDER FILLED PRODUCT. BD PAS HAS INITIATED CAPA 842998 TO FURTHER INVESTIGATE THIS ISSUE AND IMPLEMENT CORRECTIVE ACTIONS. 7. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z# PLEASE REFERENCE BD RECALL # (B)(4).
CORRECTION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT OUT OF AN ESTIMATED 11,000 OF THE BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG TUBES IN THE POSSESSION OF THE FACILITY, SOME WERE MISSING THE ADDITIVE. INVESTIGATION SUMMARY: BD HAD NOT RECEIVED SAMPLES OR PHOTOS FROM THE CUSTOMER FACILITY FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS LIMITED. 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. INVESTIGATION CONCLUSION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. ROOT CAUSE DESCRIPTION: AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. RATIONALE: COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. THE BD BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG WERE MISSED THE ADDITIVE.
IT WAS REPORTED THAT OUT OF AN ESTIMATED 11,000 OF THE BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG TUBES IN THE POSSESSION OF THE FACILITY, SOME WERE MISSING THE ADDITIVE.
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: DESCRIBE EVENT OR PROBLEM: IT WAS REPORTED THAT 226 OF THE BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG TUBES WERE MISSING ADDITIVE. 1 OF THE VACUTAINERS WAS FOUND CONTAINING A PIECE OF GLASS INSIDE THE TUBE. (B)(4).
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. 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 226 OF THE BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG TUBES WERE MISSING ADDITIVE. 1 OF THE VACUTAINERS WAS FOUND CONTAINING A PIECE OF GLASS INSIDE THE TUBE.
IT WAS REPORTED THAT BD VACUTAINER® SODIUM FLUORIDE / POTASSIUM OXALATE 100 MG / 20 MG WERE MISSED THE ADDITIVE
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1044278 | BD VACUTAINER® SODIUM FLUORIDE/POTASSIUM OXALATE 100 MG/20 MG | EVACUATED BLOOD COLLECTION TUBE IVD | JKA | BECTON, DICKINSON & CO. | 8187663 | 50382903670012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |