BD SEDISYSTEM¿ ESR INSTRUMENT
Report
- Report Number
- 2243072-2018-01030
- Event Type
- Malfunction
- Date Received
- August 3, 2018
- Date of Event
- July 18, 2018
- Report Date
- November 15, 2018
- Manufacturer
- BECTON DICKINSON
- Product Code
- JPH
- PMA / PMN Number
- N/A
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
THE OEM MANUFACTURER HAS BEEN UPDATED. (B)(4).
THE BD SEDI-15 INSTRUMENT (CATALOG NO. 366076) WAS DISCONTINUED IN JANUARY 2010 AND IS NO LONGER DISTRIBUTED BY BD. ADDITIONAL INFORMATION WAS RECEIVED ON 10/30/2018 FROM THE BD TECHNICAL SUPPORT TEAM WHO CONDUCTS A REPAIR SERVICE ON THE DEVICE REFERENCED IN THIS REPORT. IT WAS DETERMINED THAT THIS DEVICE IS NOT A BD SEDI-15 CATALOG NO. 366076, BUT RATHER A NON-BD PRINTER. A PROCESSING ERROR HAD OCCURRED WHERE THE PRINTER WAS LOGGED INTO THE SERVICE REQUEST SYSTEM AS THE ¿BD SEDI-15 CATALOG NO. 366076¿. AS A RESULT, THE CURRENT COMPLAINT REFERENCING THE BD SEDI-15 CATALOG NO. 366076 WILL BE CANCELLED IN OUR COMPLAINT SYSTEM AS IT IS NOT ASSOCIATED WITH OUR BD PRODUCTS. WE HAVE ALSO TAKEN NECESSARY ACTIONS TO PREVENT THIS PROCESSING ERROR FROM RECURRING IN THE FUTURE.
THIS SUPPLEMENTAL IS BEING FILED TO CORRECT FOLLOW UP NUMBER ON MFG REPORT# 2243072-2018-01030 FOLLOW UP 4, WHICH SHOULD HAVE BEEN FOLLOW UP 3.
DUE TO AN IT ISSUE BEGINNING ON (B)(6) 2018, PREVIOUSLY FILED EMDRS DID NOT CONTAIN REQUIRED FIELDS. THIS SUPPLEMENTAL EMDR IS FILED TO PROVIDE THE FOLLOWING OMITTED FIELDS: EVENT ATTRIBUTED TO: OTHER; DEVICE SINGLE USE?: NO; DEVICE RETURNED TO MANUFACTURE: NO. A SERVICE WORK ORDER INDICATES THAT THE INSTRUMENT WAS EVALUATED, REPAIRED, RESTARTED AND A PERFORMANCE CHECK SHOWED NO ISSUES. BASED ON THE SERVICE WORK ORDER CONDUCTED, NO ADDITIONAL ISSUES WERE OBSERVED. THE ROOT CAUSE WAS DETERMINED TO BE A LOOSE PRINTER HOLDER CARTRIDGE. THE COMPONENT WAS REPLACED AND THE DEVICE IS FUNCTIONING CORRECTLY. 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 WITH THE USE OF THE BD SEDISYSTEM ESR INSTRUMENT THERE WAS AN ISSUE WITH HARDWARE/SOFTWARE MALFUNCTION. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD SEDISYSTEM¿ ESR INSTRUMENT THERE WAS AN ISSUE WITH HARDWARE/SOFTWARE MALFUNCTION. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD SEDISYSTEM¿ ESR INSTRUMENT THERE WAS AN ISSUE WITH HARDWARE/SOFTWARE MALFUNCTION. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
IT WAS REPORTED WITH THE USE OF THE BD SEDISYSTEM ESR INSTRUMENT THERE WAS AN ISSUE WITH HARDWARE/SOFTWARE MALFUNCTION. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS (B)(4). THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN (B)(4) HAS BEEN LISTED IN SECTIONS AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED WITH THE USE OF THE BD SEDISYSTEM¿ ESR INSTRUMENT THERE WAS AN ISSUE WITH HARDWARE/SOFTWARE MALFUNCTION. THERE WAS NO REPORT OF INJURY OR FURTHER MEDICAL INTERVENTION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 587422 | BD SEDISYSTEM¿ ESR INSTRUMENT | ESR INSTRUMENT | JPH | BECTON DICKINSON | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |