SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN
Report
- Report Number
- 2243072-2020-01054
- Event Type
- Malfunction
- Date Received
- July 14, 2020
- Date of Event
- June 23, 2020
- Report Date
- August 7, 2020
- Manufacturer
- BECTON DICKINSON
- Product Code
- MMK
- PMA / PMN Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
THE FOLLOWING FIELDS WERE UPDATED DUE TO ADDITIONAL INFORMATION: D.10. DEVICE AVAILABLE FOR EVAL?: YES. D.10. RETURNED TO MANUFACTURER ON: 6/23/2020. H.6. INVESTIGATION: SAMPLES WERE RECEIVED. ACCORDING TO THE DHR REVIEW PROCESS; THE RESULT SHOWED THERE WERE NO ISSUES REPORTED LIKE ¿LID WILL NOT SHUT, OR CABLE/WIRE BROKEN/SNAPPED¿ DURING THE MANUFACTURING PROCESS OF THE LOT NUMBER REPORTED UNDER THIS CUSTOMER COMPLAINT. A NCMR WAS OPENED ON MAY 2019 TO TROLLEY FAMILY, NCMR-JRZ-00000905 WHERE THE CABLE WAS LOOSE OF TENSILE. A NCMR WAS OPENED ON MAY 2019 FOR TROLLEY FAMILY PRODUCTS, NCMR-JRZ-00000905 WHERE THE CABLE WAS LOOSE ON THE RIVET. A RE-WORK PROCESS ON RAW MATERIAL (PEDAL MECHANISM) WAS PERFORMED TO PERFORM A CORRECT CRIMPING ON THE RIVET. ACCORDING WITH THIS INVESTIGATION THE ISSUE REPORTED UNDER THIS COMPLIANT IS RELATED TO SUPPLIER ISSUE DETECTED WITHIN THE MANUFACTURING PROCESS, THEREFORE THE ROOT CAUSE IS RELATED TO MANUFACTURING PROCESS. AS PART OF THIS INVESTIGATION, A REVIEW OF CUSTOMER COMPLAINT RECORDS WAS PERFORMED; ACCORDING WITH THE CC¿S RECORDS, TWELVE ADDITIONAL COMPLAINTS WERE RECEIVED THROUGHOUT THE LAST TWELVE MONTHS FOR THE SAME PART NUMBER AND ISSUE. DUE TO THIS FAILURE MODE (COMPONENT WAS TOO LOOSE CAUSING THE MECHANISM TO BE RELEASED FROM THE RIVET) WAS REPORTED IN SEVERAL COMPLAINTS AND THE FAILURE MODE WAS CONFIRMED LIKE A FAILURE IN A COMPONENT BOUGHT (FOOT PEDAL MECHANISM) TO SUPPLIER ((B)(4)); A CAPA RECORD HAS BEEN OPENED CAR-JRZ-00000109 TO IMPLEMENT ACTIONS THAT HELPS TO DECREASE OR AVOID RECURRENCES. BASED IN THE MANUFACTURING DATE OF THE LOT REPORTED IN THE COMPLAINT IT WAS CONFIRMED THAT THE PRODUCT WAS MANUFACTURED BEFORE OF CORRECTIVE ACTIONS IMPLEMENTATION. FROM SUPPLIER FACILITY, THE FOLLOWING CORRECTIONS WERE TAKEN: 1. INCOMING MATERIAL MUST HAVE BE WELL CHECKED. FOLLOW MIL-STD-1050D AND USE GENERAL INSPECTION LEVEL II. THE INNER DIAMETER OF SLEEVES IS 2.21 MM. AND O/D IS 4.3MM. 2. CRIMPING DIE WILL BE CHECKED BEFORE THE OPERATION. 3. AFTER CRIMPING PROCESS, A SAMPLE FOLLOWING THE TABLE MIL-STD_1050D INSPECTION LEVEL I WILL BE TAKEN PERFORM A PULL TEST TO MAKE SURE THE CABLE CAN¿T BE NO RELEASED BELOW 200LBS FORCE.
IT WAS REPORTED THAT THE SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN EXPERIENCED A LID THAT WAS DIFFICULT TO CLOSE/WOULD NOT CLOSE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LID OF THE CART DOESN'T OPEN OR SHUT PROPERLY. THE WIRE WAS LOOSE.
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4). OEM MANUFACTURE: 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 AND THE (B)(4) FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
IT WAS REPORTED THAT THE SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN EXPERIENCED A LID THAT WAS DIFFICULT TO CLOSE/WOULD NOT CLOSE. PRODUCT DEFECT WAS NOTED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE LID OF THE CART DOESN'T OPEN OR SHUT PROPERLY. THE WIRE WAS LOOSE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 733030 | SHARPS COLL TROLY FOOT-OP 19GL RECYKLEEN | SHARPS CONTAINER | MMK | BECTON DICKINSON | 9158901 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |