BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE
Report
- Report Number
- 1917413-2019-01627
- Event Type
- Malfunction
- Date Received
- June 21, 2019
- Date of Event
- June 3, 2019
- Report Date
- July 18, 2019
- Manufacturer
- BECTON, DICKINSON & CO. (BROKEN BOW)
- 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
- TX, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: THIS COMPLAINT IS UNDER THE SCOPE OF FIELD ACTION # PAS-19-1461. 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. BD HAS INITIATED FURTHER INVESTIGATION RELATING TO THIS ISSUE THROUGH A CAPA AND POTENTIAL CAUSES HAVE BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS HAVE BEEN ESTABLISHED AND ARE IN THE PROCESS OF BEING IMPLEMENTED. AS NO SAMPLES OR PHOTOS WERE RECEIVED FOR EVALUATION, THE CUSTOMER'S INDICATED FAILURE MODE WAS NOT OBSERVED BY BD. HOWEVER, FURTHER INVESTIGATION ACTIVITIES HAVE BEEN CONDUCTED THROUGH A CAPA AND THE MOST LIKELY ROOT CAUSE HAS BEEN IDENTIFIED. AS A RESULT, CORRECTIVE ACTIONS AND PROCEDURES ARE BEING IMPLEMENTED TO MITIGATE FURTHER OCCURRENCES. ALTHOUGH NO SAMPLES OR PHOTOS WERE AVAILABLE FOR EVALUATION, BD HAS INITIATED FURTHER INVESTIGATION THROUGH A CAPA. THE CAPA HAS IDENTIFIED THE MOST LIKELY ROOT CAUSES AND CORRECTIVE ACTIONS ARE IN THE PROCESS OF BEING IMPLEMENTED. CAPA 842998. 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. H3 OTHER TEXT : SEE SECTION H.10.
ADDITIONAL INFORMATION: H.7. REMEDIAL ACTION REQUIRED: THIS INFORMATION IS ASSOCIATED WITH FIELD ACTION # 2243072-05/09/2019-008-R. 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. PRODUCT AND SCOPE: BD VACUTAINER® FLUORIDE TUBES FOR BLOOD ALCOHOL DETERMINATIONS. 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. SUMMARY TABLE OF THE # OF COMPLAINTS AND MDRS IN SCOPE: PER 806 # 2243072-05/09/2019-008-R DATED JUNE 28, 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. 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. 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. RECALL REFERENCE #, EITHER BD INTERNAL OR RES/Z#. PLEASE REFERENCE BD RECALL # PAS-19-1461.
IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE TUBES WERE ARRIVE CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. (PATIENT 7/9). I AM CONTACTING YOU IN REGARDS TO THE ATTACHED BATCH OF GRAY TOP TUBE KITS WE HAVE RECEIVED INTO OUR LABORATORY AS CASE SPECIMENS. WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER." 7 OCCURRENCES WERE REPORTED AFTER USE.
IT WAS REPORTED THAT CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE TUBES WERE ARRIVE CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. (PATIENT 7/9) I AM CONTACTING YOU IN REGARDS TO THE ATTACHED BATCH OF GRAY TOP TUBE KITS WE HAVE RECEIVED INTO OUR LABORATORY AS CASE SPECIMENS. WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER." 7 OCCURRENCES WERE REPORTED AFTER USE.
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 CLOTTING OCCURRED AFTER USE WITH A BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, "IT WAS REPORTED THE TUBES WERE ARRIVE CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. (PATIENT 7/9). I AM CONTACTING YOU IN REGARDS TO THE ATTACHED BATCH OF GRAY TOP TUBE KITS WE HAVE RECEIVED INTO OUR LABORATORY AS CASE SPECIMENS. WE HAVE AT LEAST SEVEN DIFFERENT CASE SPECIMENS IN THIS SPECIFIC BATCH THAT HAVE ARRIVED CLOTTED WHICH MAKES TESTING DIFFICULT AND POTENTIALLY IMPOSSIBLE. WE REACHED OUT TO THE SUBMITTING AGENCIES AND THEY WERE ALL TAKEN FROM DIFFERENT COLLECTION SITES, SO THE ONLY THING IN COMMON WITH THIS PROBLEM WAS THE CATALOG AND BATCH NUMBER."7 OCCURRENCES WERE REPORTED AFTER USE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 518800 | BD VACUTAINER® BLOOD ALCOHOL DETERMINATIONS SODIUM FLUORIDE | BLOOD SPECIMEN COLLECTION DEVICE | JKA | BECTON, DICKINSON & CO. (BROKEN BOW) | 8187663 | 50382903670012 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR | Other |