BD ACCURI¿
Report
- Report Number
- 2916837-2022-00094
- Event Type
- Malfunction
- Date Received
- April 12, 2022
- Date of Event
- January 27, 2022
- Report Date
- July 15, 2022
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- OYE
- PMA / PMN Number
- BK150307
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
MEDICAL DEVICE EXPIRATION DATE: NA. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED, BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFO: G.5. PMA / 510(K)#: BK150307. ADDITIONAL INFO: THE EVENT DESCRIBED OCCURRED ON AN RUO INSTRUMENT, BUT IT IS CONSIDERED TO BE SUBSTANTIALLY SIMILAR TO THE LEGALLY U.S. MARKETED IVD VERSION OF THE INSTRUMENT. THE IVD INSTRUMENT¿S 510K HAS BEEN REPORTED.
H.6. INVESTIGATION: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO BD ACCURI C6 PLUS SYSTEM, PART # 660517, AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED A COMPLAINT REGARDING A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 27JAN2020 TO DATE 27JAN2022. ¿ COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO THE ISSUE OF A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 27JAN2020 TO DATE 27JAN2022. ¿ MANUFACTURING DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART #660517, SERIAL # (B)(6), FILE #660517-660517-R660517590166-105230809-17, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF THE COMPLAINT TREND, DEFECT TREND, DHR, RISK ANALYSIS AND SERVICEMAX, THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO CLOGGED VALVES. THE CUSTOMER HAD INITIALLY REPORTED THAT THE WASTE TUBING WOULD REPEATEDLY POP OFF AND THAT THE BLACK RUBBER GASKETS HAD DETERIORATED AND NEEDED TO BE REPLACED. THE INSTRUMENT WAS DISPATCHED TO THE REPAIR DEPOT. THE TECHNICIAN PERFORMING THE REPAIR REPLACED THE CLOGGED VALVES (PN 660484) AND DIRTY DAMPENERS (PN 660490) TO RESOLVE THE ISSUE OF A LEAKAGE. ADDITIONALLY, THE TECHNICIAN PERFORMED A PREVENTATIVE MAINTENANCE ON THE INSTRUMENT BY REPLACING SEVERAL FILTERS AND THE PERISTALTIC TUBING. NO PARTS WERE REQUESTED FOR EVALUATION AS THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. AFTER THE REPAIRS THE INSTRUMENT WAS FUNCTIONING AS EXPECTED WITH NO FURTHER LEAKAGES. ALTHOUGH THE LEAKAGE WAS OF A BIOHAZARDOUS MATERIAL THAT POSES THE RISK OF CONTAMINATION, THE CUSTOMER CONFIRMED THAT THEY HAD NOT COME IN CONTACT WITH THE LIQUID AND WERE NOT HARMED IN ANY WAY. ADDITIONALLY, THE LEAKAGE WAS NOT UNDER PRESSURE AND THUS DID NOT INCREASE THE RISK OF EXPOSURE. PROPER DAILY AND MONTHLY CLEANING AND MAINTENANCE CAN HELP IN MAINTAINING OPTIMAL PERFORMANCE THE SYSTEM AND DETECTING ISSUES BEFORE THEY LEAD TO FAILURES, AND CAN BE FOUND IN THE BD ACCURI C6 PLUS SYSTEM USER¿S GUIDE, #23-18013-01 REV. 1/VERS. A. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL. ¿ SERVICE MAX REVIEW: REVIEW OF RELATED WORK ORDER #: 02308384, CASE # (B)(4). INSTALL DATE: 09MAR2018. DEFECTIVE PART NUMBER: 660484 - ASSY VALVE BOARD DIAPHRAGM VALVES SVC. 660490 - ASSY SINGLE PULSE DAMPENER SERVICE. WORK ORDER NOTES: O SUBJECT / REPORTED: WORN TUBING AND GASKETS. O PROBLEM DESCRIPTION: THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. PLEASE SEND OUT A LOANER UNIT ASAP. O WORK PERFORMED: REPLACING VALVES ¿ FIXED THE CUSTOMER ISSUE. REPLACED COMPONENTS TO PASS SPECIFICATIONS: VALVES (CLOGGED), DAMPENERS (DIRTY). REPLACED PREVENTIVE MAINTENANCE COMPONENTS: FILTER HALF-SHELL, FILTER IN-LINE SHEATH, TUBING PUMP PERISTALTIC. O CAUSE: WORN TUBING AND GASKETS CAUSED BY DEFECTIVE VALVES. O SOLUTION: ABLE TO REPRODUCE CUSTOMER COMPLAINT. THE INSTRUMENT PASSES ALL SPECIFICATIONS. ¿ RETURNED SAMPLE EVALUATION: A RETURN SAMPLE WAS NOT REQUESTED BECAUSE THE REPLACED PARTS ARE NOT RETURNABLE AND WERE DISCARDED. ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 07/VERS. AA, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? YES OR NO? O TFS: 93860. O ID: LIBIVD-RA-490 3.1.145. O REG STATUS: IVD; RUO. O HAZARD: POTENTIAL FOR WRONG RESULT. O CAUSE: PUMP OR VALVE FAILURE DURING ACQUISITION WITHOUT NOTIFICATION TO USER. O HARMFUL EFFECTS: WRONG RESULT WITHOUT ANY WARNING AND LOSS OF SAMPLE. O RISK CONTROL: FIRMWARE WILL DETECT FAILURE OF THE COMPONENT AT THE START OF THE NEXT ACQUISITION AND NOTIFY FACSUITE CLINICAL SOFTWARE OR THE FACSUITE SOFTWARE TO INFORM THE USER. VACUUM PRESSURE IS MONITORED DURING ACQUISITION. IF PRESSURE DROPS THE USER IS NOTIFIED. O REQ LINK (TFS ID): N/A. O IMPLEMENTATION VERIFICATION: LSVN 1024, LIBIVD-15-72P. O EFFECTIVENESS VERIFICATION: LSVN 1024, LIBIVD-15-72F. O PROBABILITY: 1. O SEVERITY: 3. O RISK INDEX: 3. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. O TFS: 89178. O ID: LIBIVD-RA-72 2.1.15. O REG STATUS: IVD; RUO. O HAZARD: EXPOSURE TO BIOLOGICAL SAMPLE. O CAUSE: FAILED WASTE CONNECTION. O HARMFUL EFFECTS: DAMAGE TO INSTRUMENT. O RISK CONTROL: ROBUST DESIGN CONNECTION TO THE TANK. THE WASTE CONNECTION TO THE CHASSIS IS HOUSED INSIDE THE SYSTEM. SYSTEM SHALL BE DESIGNED TO ISOLATE FLUID FROM ELECTRICAL AND OPTICAL COMPONENTS. WASTE CAP REMOVED INTERLOCK. O REQ LINK (TFS ID): 93748 LIBIVD-DID-1582 SHIELDING. O IMPLEMENTATION VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-53IR, LIBIVD-SE-15-72P. O EFFECTIVENESS VERIFICATION: LIBIVD-SE-15-84AR, LIBIVD-SE-15-53IR, LIBIVD-SE-15-72F. O PROBABILITY: 1. O SEVERITY: 3. O RISK INDEX: 3. O RESIDUAL RISK EVALUATION: A. O NEW HAZARDS: NONE. MITIGATION(S) SUFFICIENT: YES OR NO? ¿ ROOT CAUSE: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO CLOGGED FLUIDICS VALVES. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS THE ROOT CAUSE OF THE WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT WAS DUE TO CLOGGED FLUIDICS VALVES. THE FAULTY INSTRUMENT WAS SENT TO THE REPAIR DEPOT FOR REPAIR. THE SERVICE TECHNICIAN REPLACED THE CLOGGED VALVES AND DIRTY DAMPENERS TO RESOLVE THE CUSTOMER ISSUE. AS A PREVENTATIVE MAINTENANCE, THE TECHNICIAN ALSO REPLACED SEVERAL FILTERS AND THE PERISTALTIC TUBING. AFTER THE REPAIR, THE INSTRUMENT WAS REBOOTED, TESTED, AND FUNCTIONING AS EXPECTED. NO ONE WAS HARMED OR INJURED, AND NO MEDICAL DIAGNOSIS WAS PERFORMED DUE TO THE LEAKAGE. THE SAFETY RISK OF THIS HAZARD HAS BEEN IDENTIFIED TO BE WITHIN THE ACCEPTABLE LEVEL.
INVESTIGATION SUMMARY HAS BEEN CORRECTED. FROM ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000063058RA, REV. 07/VERS. AA, BD FACSLYRIC SYSTEM RISK ANALYSIS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. TO ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000214703, REV. 01/VERS. A, RISK ANALYSIS ACCURI C6 PLUS WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT.
THE FOLLOWING LINES FROM THE INVESTIGATION HAS BEEN CORRECTED: H.6. INVESTIGATION: ¿ MANUFACTURING DEFECT TREND: THERE ARE 0 QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE. DATE RANGE FROM 27JAN2021 TO DATE 27JAN2022. ¿ COMPLAINT TREND: THERE ARE 4 COMPLAINTS RELATED TO THE ISSUE OF A WASTE LEAKAGE NOT CONTAINED WITHIN THE INSTRUMENT. DATE RANGE FROM 27JAN2021 TO DATE 27JAN2022.
IT HAS BEEN REPORTED THAT THE BD ACCURI¿ HAS BEEN FOUND LEAKING UNCONTAINED BIOHAZARD. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS WORN TUBING AND GASKETS. THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. 09 APR 2022 METHIRAN VENKATRAMAN (IST) FROM SMAX CASE (B)(4) CHECK LIST. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.
IT HAS BEEN REPORTED THAT THE BD ACCURI¿ HAS BEEN FOUND LEAKING UNCONTAINED BIOHAZARD. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS WORN TUBING AND GASKETS. THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. 09 APR 2022 METHIRAN VENKATRAMAN (IST) FROM SMAX CASE (B)(4) CHECK LIST : WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.
IT HAS BEEN REPORTED THAT THE BD ACCURI¿ HAS BEEN FOUND LEAKING UNCONTAINED BIOHAZARD. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS WORN TUBING AND GASKETS. THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. 09 APR 2022 METHIRAN VENKATRAMAN (IST) FROM SMAX CASE (B)(4) CHECK LIST. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.
IT HAS BEEN REPORTED THAT THE BD ACCURI¿ HAS BEEN FOUND LEAKING UNCONTAINED BIOHAZARD. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS WORN TUBING AND GASKETS. THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. 09 APR 2022 METHIRAN VENKATRAMAN (IST) FROM SMAX CASE (B)(4) CHECK LIST. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.
IT HAS BEEN REPORTED THAT THE BD ACCURI¿ HAS BEEN FOUND LEAKING UNCONTAINED BIOHAZARD. THE FOLLOWING HAS BEEN PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED THAT THERE IS WORN TUBING AND GASKETS. THE CUSTOMER REPORTS VIA EMAIL THAT THE RED WASTELINE TUBING CONSTANTLY POPS OFF AND THE BLACK RUBBER GASKETS THAT THE TUBING PASSES THROUGH HAS DETERIORATED OVER TIME AND NEEDS TO BE REPLACED. 09 APR 2022 METHIRAN VENKATRAMAN (IST) FROM SMAX CASE 01582851 CHECK LIST WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): NOT CONTAINED. WAS THERE SPRAY OF LIQUID? (IF YES, DESCRIBE THE LIQUID THAT SPRAYED THEN GO TO QUESTION #7. IF NO, TYPE "NO" IN THE TEXT BOX THEN GO TO QUESTION #4): NO. WHAT WAS THE FLUID THAT LEAKED? (IF NON BIOHAZARD, NO FURTHER QUESTIONS REQUIRED. IF BIOHAZARD/UNKNOWN, GO TO QUESTION #5): BIOHAZARD DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? (IF BEFORE WASTE LINE OR UNKNOWN, GO TO QUESTION #7. IF AFTER WASTE LINE, GO TO QUESTION #6): AFTER WASTE LINE. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? (IF NO, GO TO QUESTION #7. IF YES, NO FURTHER QUESTIONS REQUIRED.): NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? (IF YES, GO TO QUESTION #8. IF NO, NO FURTHER QUESTIONS REQUIRED.) PHYSICAL CONTACT INCLUDES: CLOTHING, SKIN, MUCOUS MEMBRANE, INHALATION, AND NON-INTACT SKIN.: NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1130704 | BD ACCURI¿ | NA | OYE | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |