BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP
Report
- Report Number
- 2243072-2019-00208
- Event Type
- Malfunction
- Date Received
- February 11, 2019
- Date of Event
- January 24, 2019
- Report Date
- March 12, 2019
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 50382903053433
- PMA / PMN Number
- K943134
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
H.6. INVESTIGATION SUMMARY: NO SAMPLES OF PHOTOS WERE RECEIVED. ADDITIONAL ATTEMPTS TO GET MORE INFORMATION OR PICTURES WERE MADE, HOWEVER IN NONE OF THE CASES ADDITIONAL INFORMATION WERE PROVIDED. THE DHR REVIEW PROCESS WAS NOT PERFORMED DUE TO THE LOT NUMBER WAS NOT PROVIDED FROM CUSTOMER A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE MISSING STICKER FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. INVESTIGATION: DUE TO NO SAMPLES OR PICTURES WERE PROVIDED IN THIS COMPLAINT, IT WAS REVIEWED THE CUSTOMER COMPLAINT RECORDS; ACCORDING WITH THE CC¿S RECORDS, 4 ADDITIONAL COMPLAINTS WERE RECEIVED THROUGH THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE, FOR THIS REASON THE CURRENT CONTROLS WITHIN THE PROCESS WERE REVIEWED AND IT WAS FOUND THAT THIS CHARACTERISTIC IS VISUALLY INSPECTED BY PRODUCTION DEPARTMENT AND A SECOND INSPECTION BASED ON AN AQL SAMPLING PLAN IS PERFORMED BY QUALITY INSPECTOR; HOWEVER, THE PROBABILITY TO OMIT IT BY ERROR COULD HAPPENED. A REVIEW OF THE DHRS FOR THE LAST 6 LOTS 9039924, 9040926, 9041927, 9042927, 9043964, AND 9044922 MANUFACTURED FOR THE PART NUMBER 305343, THIS RESULT DOESN¿T SHOWED ISSUES LIKE NCMR¿S DURING THE MANUFACTURING PROCESS. ACCORDING WITH THE CAPA RECORDS A CORRECTIVE ACTION #CA-J1001156 WERE PERFORMED TO AVOID THE MISSING LIDS ISSUES SINCE MAR-3-2016, HOWEVER DUE TO THE LOT NUMBER WAS NOT PROVIDED, IT WAS NOT POSSIBLE CONFIRM IF THE PRODUCT REPORTED UNDER THIS COMPLAINT AROSE FROM A LOT MANUFACTURED BEFORE OR AFTER OF THE CORRECTIVE ACTION IMPLEMENTATION. CONCLUSION: BASED ON THIS INVESTIGATION IT WAS CONFIRMED THIS ISSUE LIKE A PROBLEM RELATED TO MANUFACTURING PROCESS HOWEVER THERE IS NO ENOUGH INFORMATION TO DETERMINE IF THIS ISSUE AROSE FROM A LOT MANUFACTURED BEFORE OR AFTER THE IMPLEMENTATION OF THE CORRECTIVE ACTION #CA-J1001156. THE CONTROLS WERE REVIEWED AND IT WAS CONFIRMED THAT THERE ARE CONTROLS ALREADY IMPLEMENTED WITHIN THE PROCESS THROUGH VISUAL INSPECTIONS; AS PART OF THE FOLLOWING-UP TO THIS COMPLAINT, A QUALITY ALERT MED-QAJ-C-1676 WAS POSTED IN THE MANUFACTURING PROCESS TO MAKE AWARE ALL PEOPLE INVOLVED IN THE MANUFACTURING OF THIS PRODUCT; ACCORDING TO RISK ASSESSMENT RESULT A NEW CORRECTIVE ACTION IS NOT REQUIRED HOWEVER AS PART OF FOLLOWING UP ACTIVITIES OVER THIS COMPLAINT, AN AUTOMATIC DEVICE TO DETECT THE LACK OF LABEL WILL BE REQUESTED TO ENGINEERING DEPARTMENT TO ELIMINATE OR MINIMIZE RECURRENCES RELATED TO THIS ISSUE. ALL THE COMPLAINT INFORMATION WAS CAPTURED FOR TRACKING AND TRENDING PURPOSES.
IT WAS REPORTED WITH THE USE OF THE BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP THERE WERE 2 ISSUES WITH STICKER MISSING ON THE COLLECTOR.
MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
IT WAS REPORTED WITH THE USE OF THE BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP THERE WERE 2 ISSUES WITH STICKER MISSING ON THE COLLECTOR.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 117885 | BD¿ MULTI-USE NESTABLE SHARP COLLECTOR, 8 QT HINGE CAP | SHARPS COLLECTOR | FMI | BECTON DICKINSON | UNKNOWN | 50382903053433 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |