inforMED
MalfunctionPER

BD FACS SPA III (337170 UPGRADED)

Received Jul 13, 2022 · Event occurred Jun 27, 2022

Report 2916837-2022-00183 · MDR key 15005269

Device

Generic name

Automated Pipetting, Flow Cytometric Analysis

Catalog number

650686

Product problems

  • Fluid/Blood Leak
  • Fluid/Blood Leak

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD FACS SPA III (337170 UPGRADED) THE DEVICE EXPERIENCED LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LEAK CHECKLIST: 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID? NO. 4. WHAT WAS THE FLUID THAT LEAKED? NON-BIOHAZARD. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS ISSUES WITH THE OVERFLOW WASHING STATION.

Additional Manufacturer Narrative

A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION HAS BEEN RECEIVED CHANGING THE INITIAL REPORTABILITY OF THE RECORD. PLEASE SEE THE INFORMATION PROVIDED BELOW FOR THE UPDATED FIELDS. MFR REPORT # 2916837-2022-00183 WILL BE CLOSED AS NOT REPORTABLE. B.5. EVENT DESCRIPTION: IT WAS REPORTED WHEN USING THE BD FACS SPA III (337170 UPGRADED) THE DEVICE EXPERIENCED WASTE LEAKAGE WITH BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LEAK CHECKLIST: 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID? NO. 4. WHAT WAS THE FLUID THAT LEAKED? NON-BIOHAZARD. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS ISSUES WITH THE OVERFLOW WASHING STATION. ADDITIONAL INFORMATION: IN THE PARENT RECORD: IT WAS BLEACH. OVERFLOW HAPPENED DURING CLEANING CYCLE.

Description of Event or Problem

IT WAS REPORTED WHEN USING THE BD FACS SPA III (337170 UPGRADED) THE DEVICE EXPERIENCED WASTE LEAKAGE WITH BLEACH NOT CONTAINED (OUTSIDE INSTRUMENT). THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: LEAK CHECKLIST: 1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. WAS THERE SPRAY OF LIQUID? NO. 4. WHAT WAS THE FLUID THAT LEAKED? NON-BIOHAZARD. IT WAS REPORTED BY THE CUSTOMER THAT THERE WAS ISSUES WITH THE OVERFLOW WASHING STATION. ADDITIONAL INFORMATION: IN THE PARENT RECORD: IT WAS BLEACH. OVERFLOW HAPPENED DURING CLEANING CYCLE.