BD RECYKLEEN¿ FOOT-OPERATED TROLLEY
Report
- Report Number
- 2243072-2023-00481
- Event Type
- Malfunction
- Date Received
- March 25, 2023
- Date of Event
- March 7, 2023
- Report Date
- April 20, 2023
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 00382903050932
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H6: INVESTIGATION SUMMARY: NO PRODUCT WAS RETURNED BY THE CUSTOMER. PHOTOS AND VIDEO REPRESENTATION WAS PROVIDED FOR THE COMPLAINT INVESTIGATION. ACCORDING TO THE DHR REVIEW PROCESS, THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE TROLLEY DEFECTIVE DURING THE MANUFACTURING PROCESS FOR THE LOT NUMBER (3072933) REPORTED UNDER THIS COMPLAINT. A REVIEW OF THE NCMR¿S WAS PERFORMED; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE TROLLEY DEFECTIVE FOR THE SAME PART NUMBER THROUGHOUT THE LAST TWELVE MONTHS. INVESTIGATION: BASED ON THE PICTURES AND INFORMATION PROVIDED, IT CAN BE MENTIONED THE FOLLOWING: WIRE IS LOOSE FROM THE PEDAL MECHANISM. WITHIN GLOBAL COMPLAINT DETAIL REPORT, IT¿S MENTIONED CUSTOMER REPORTED THAT TROLLEY DID NOT CLOSE. ONE IS FULLY BROKEN AND THE OTHER DOES NOT CLOSED LID WITH FOOT PEDAL. IT CAN BE NOTICED THAT THIS IS A KNOWN FAILURE MODE (FAILURE/DAMAGED WIRE) SINCE IT HAS BEEN REPORTED IN PREVIOUS COMPLAINTS. THIS FAILURE MODE WAS CONFIRMED LIKE A FAILURE IN A COMPONENT (FOOT PEDAL MECHANISM) BOUGHT TO A SUPPLIER FOR THIS REASON A CAPA RECORDS WERE OPENED TO IMPLEMENT CORRECTIVE ACTIONS THAT HELPS TO DECREASE OR AVOID RECURRENCES. BASED ON THE LOT NUMBER PROVIDED, IT¿S POSSIBLE TO CONFIRM THAT THIS PRODUCT WAS MANUFACTURED ON FEBRUARY, 2023 WHICH MEANS THAT THIS WAS MANUFACTURED AFTER CORRECTIVE ACTIONS¿ IMPLEMENTATION, BECAUSE OF THIS, THE CURRENT RAW MATERIAL (MECHANISM) WAS VERIFIED TO CONFIRM IF RIVETS ARE BEING RECEIVED WITH CORRECT CRIMPING. THIS VERIFICATION SHOWED THAT CABLE HAVE VARIATION ON THE CRIMPING FORCE (THIS WAS VERIFIED THROUGH A FUNCTIONAL PULL-TEST). FOR THIS REASON, IMPROVEMENTS HAVE BEEN MADE TO REINFORCE THE MECHANISM (WIRE) CRIMPING WITHIN OUR PROCESS BY ADDING THE PROCESS TO CRIMP THE WIRE WHEN THE RIVET HAS NO CRIMP MARKS. IN ADDITION, A NOTIFICATION WILL BE ISSUED TO SUPPLIERS TO INFORM THEM OF THIS RAW MATERIAL ISSUE. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING WITH THE CC¿S RECORDS, NO ADDITIONAL COMPLAINTS WERE RECEIVED THROUGHOUT THE LAST TWELVE MONTHS FOR THE SAME LOT NUMBER AND ISSUE. HOWEVER, IN PREVIOUS COMPLAINTS REPORTING SAME ISSUE FROM THE SAME FAMILY, IT WAS CONCLUDED THAT THE FAILURE MODE IS RELATED TO THE MANUFACTURING PROCESS AND IT WAS CONFIRMED THAT AFTER THE IMPLEMENTATION THERE WERE NO COMPLAINTS REPORTED FOR THE SAME ISSUE. DUE TO NO SAMPLE BEING RECEIVED, AN INVESTIGATION COULD NOT BE PERFORMED, AND A ROOT CAUSE COULD NOT BE DETERMINED. HOWEVER POTENTIAL ROOT CAUSE WILL BE: THE LACK OF CRIMPING IN THE CABLE. END USER MISUSE (THE END USER DIDN¿T FOLLOW THE STEPS STATED IN THE BD SHARPS COLLECTOR IFU). BASED ON THIS INVESTIGATION, THIS ISSUE WAS ALREADY KNOWN IN THE PROCESS DUE TO A SUPPLIER ISSUE DETECTED WITHIN THE MANUFACTURING PROCESS (THE CRIMPING ON THE RIVET OF FOOT PEDAL MECHANISM IT WASN¿T DONE CORRECTLY). CORRECTIVE ACTIONS WERE IMPLEMENTED BY FLEX AND YANG JU INDUSTRIES CORP SUPPLIER TO PREVENT THIS ISSUE, THIS IMPROVEMENT ACTIONS WERE DOCUMENTED UNDER CAPA. FULL IMPLEMENTATION OF CORRECTIVE ACTIONS WAS COMPLETED SINCE AUGUST 2019 AND MARCH 2020 AS EFFECTIVE, HOWEVER, WITH LOT NUMBER PROVIDED WE ARE ABLE TO CONFIRM THAT PRODUCT REPORTED WAS MANUFACTURED AFTER THESE IMPLEMENTATIONS, FOR THIS REASON, THERE HAS BEEN IMPROVEMENTS TO REINFORCE THE CRIMPING OF THE MECHANISM (CABLE) WITHIN OUR PROCESS BY ADDING THE PROCESS TO CRIMP THE CABLE WHEN THE RIVET HAS NO MARKS OF CRIMPING. IN ADDITION, A SUPPLIER NOTIFICATION WILL BE EMITTED TO AWARE THEM ABOUT THIS ISSUE ON THE RAW MATERIAL.
THE MANUFACTURING LOCATION FOR THIS PRODUCT IS FLEXTRONICS. THIS SITE IS AN OEM MANUFACTURING SITE. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER. 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.
IT WAS REPORTED WHILE USING BD RECYKLEEN¿ FOOT-OPERATED TROLLEY THE LID WOULD NOT PROPERLY CLOSE AND WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305093, BATCH # UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT CHEMO TROLLEY BINS DO NOT CLOSE, ONE IS FULLY BROKEN, OTHER FOOT PEDAL DOES NOT CLOSE IT. VERBATIM: WE RECEIVED THE NEW CHEMO TROLLEY BINS AND PUT THEM IN INFUSION 1 SO FAR. THEY STILL DO NOT CLOSE. ONE OF THEM IS FULLY BROKEN AND DOESN'T OPEN OR CLOSE. THE OTHERS THE FOOT PEDAL STILL DOESN'T CLOSE IT.
IT WAS REPORTED WHILE USING BD RECYKLEEN¿ FOOT-OPERATED TROLLEY THE LID WOULD NOT PROPERLY CLOSE AND WAS DAMAGED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 305093, BATCH # UNKNOWN. IT WAS REPORTED BY THE CUSTOMER THAT CHEMO TROLLEY BINS DO NOT CLOSE, ONE IS FULLY BROKEN, OTHER FOOT PEDAL DOES NOT CLOSE IT. VERBATIM: WE RECEIVED THE NEW CHEMO TROLLEY BINS AND PUT THEM IN INFUSION 1 SO FAR. THEY STILL DO NOT CLOSE. ONE OF THEM IS FULLY BROKEN AND DOESN'T OPEN OR CLOSE. THE OTHERS THE FOOT PEDAL STILL DOESN'T CLOSE IT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 368433 | BD RECYKLEEN¿ FOOT-OPERATED TROLLEY | HYPODERMIC SINGLE LUMEN NEEDLE | FMI | BECTON DICKINSON | 3027933 | 00382903050932 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |