BD FEMALE LUER LOK ADAPTER
Report
- Report Number
- 1911916-2023-00539
- Event Type
- Malfunction
- Date Received
- August 1, 2023
- Date of Event
- July 7, 2023
- Report Date
- December 4, 2023
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FPA
- UDI-DI
- 70885403484263
- PMA / PMN Number
- K790108
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MX
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
H6: INVESTIGATION SUMMARY A COMPLAINT OF FOREIGN MATERIAL ON PRODUCT WAS RECEIVED FROM THE CUSTOMER. THE SUPPLIER OF THIS COMPONENT, NORTH AMERICAN MOLDING CENTER (NAMC), WAS NOTIFIED OF THIS DEFECT. AN INVESTIGATION WAS PERFORMED AT NAMC WITH THE MOLDING ENGINEERING, PROCESS ENGINEERING, PRODUCTION AND CONTROLS ENGINEERING GROUPS, REGARDING THE COMPLAINT AND THE DEFECT PRESENT. PHOTOS WERE PROVIDED BY THE CUSTOMER WHERE BLACK EMBEDDED FOREIGN MATTER WAS SEEN. A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT #3059001. THERE WERE NO QUALITY NOTIFICATIONS OR IN-PROCESS INSPECTION NON CONFORMANCES FOUND DURING THE PRODUCTION OF THE PARTS RELATED TO THE CONDITION MENTIONED IN THE COMPLAINT. DUE TO A PHYSICAL SAMPLE NOT BEING RECEIVED, THE DEFECT COULD NOT BE CONFIRMED AT NAMC. H3 OTHER TEXT : SEE H10.
A DEVICE HISTORY REVIEW WAS PERFORMED ON THE REPORTED LOT #3059001. THERE WERE NO QUALITY NOTIFICATIONS OR IN-PROCESS INSPECTION NON CONFORMANCES FOUND DURING THE PRODUCTION OF THE PARTS RELATED TO THE CONDITION MENTIONED IN THE COMPLAINT. INVESTIGATION WAS PERFORMED AT NAMC WITH THE MOLDING ENGINEERING, PROCESS ENGINEERING, PRODUCTION AND CONTROLS ENGINEERING GROUPS, REGARDING THE COMPLAINT AND THE DEFECT PRESENT. PHOTOS WERE PROVIDED BY THE CUSTOMER WHERE BLACK EMBEDDED FOREIGN MATTER WAS SEEN. (B)(4) SAMPLES WERE RECEIVED FOR INVESTIGATION. (B)(4) SAMPLES FAILED WITH THE FOREIGN MATTER BEING FOUND ON THE SAMPLES. EVALUATION OF THE SAMPLES RECEIVED BY NAMC CONFIRMS THE DEFECT ON THE PARTS BEING THE MATERIAL DEGRADATION FROM SCREW TO BARREL DUE TO THE NATURE OF PVC DEGRADATION PRONE TO HIGH TEMPERATURE DURING DOWNTIME OR ANY START AND STOP EVENTS OF THE PRESS. THE AFFECTED PRODUCTS FROM LOT #3059001 WILL BE DISPOSED AS SCRAP.
IT WAS REPORTED WHILE USING BD FEMALE LUER LOK ADAPTER FOREIGN MATTER WAS FOUND. THIS OCCURRED 69 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCOMING INSPECTION AT XXX OPENED A NC DUE TO A CONNECTOR (PN 1023-130-071) THAT WAS FOUND WITH FOREIGN MATERIAL ATTACHED YOU CAN FIND THE FRM-001621 ¿SUPPLIER NON-CONFORMANCE NOTIFICATION¿ WITH MORE DETAILS ABOUT THIS NC: ON JULY 7 2023, AT XXX PLANT, DURING THE INCOMING INSPECTION OF MATERIAL R-90117-001 LOT 13P23G0018 QTY 100,000 EA, IT WAS DETECTED THAT THE MATERIAL CONTAINED FOREIGN MATERIAL. SAMPLE OF 500 EA, REJECT WITH 8 EA AND 61 EA WERE FOUND WITH THIS DEFECT. RESPONSE RECEIVED ON 19-JUL-2023. IS THERE SAMPLE AVAILABLE TO RETURN FOR EVALUATION? IF YES, CAN YOU PROVIDE FACILITY ADDRESS FOR US TO GENERATE FEDEX LABEL? YES, WE CAN SEND YOU A SAMPLE, HOW MANY PIECES WOULD YOU LIKE US TO SEND YOU? WHERE WAS THE FOREIGN MATTER LOCATED? INSIDE THE FLUID PATH OR OUTSIDE ON THE SURFACE OF THE PRODUCT? IT LOOKS LIKE THE FOREIGN MATERIAL IS MIXED WITH THE MAIN MATERIAL. CAN YOU IDENTIFY THE FOREIGN MATTER? NO, IT¿S NOT POSSIBLE FOR US TO IDENTIFY THE FOREIGN MATERIAL. IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC / NEEDLE? IT¿S EMBEDDED IN THE PLASTIC.
IT WAS REPORTED WHILE USING BD FEMALE LUER LOK ADAPTER FOREIGN MATTER WAS FOUND. THIS OCCURRED 69 TIMES. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INCOMING INSPECTION AT XXX OPENED A NC DUE TO A CONNECTOR (PN 1023-130-071) THAT WAS FOUND WITH FOREIGN MATERIAL ATTACHED YOU CAN FIND THE FRM-001621 ¿SUPPLIER NON-CONFORMANCE NOTIFICATION¿ WITH MORE DETAILS ABOUT THIS NC: ON (B)(6) 2023, AT XXX PLANT, DURING THE INCOMING INSPECTION OF MATERIAL R-90117-001 LOT 13P23G0018 QTY (B)(4) EA, IT WAS DETECTED THAT THE MATERIAL CONTAINED FOREIGN MATERIAL. SAMPLE OF 500 EA, REJECT WITH 8 EA AND 61 EA WERE FOUND WITH THIS DEFECT. RESPONSE RECEIVED ON 19-JUL-2023. ¿ IS THERE SAMPLE AVAILABLE TO RETURN FOR EVALUATION? IF YES, CAN YOU PROVIDE FACILITY ADDRESS FOR US TO GENERATE FEDEX LABEL? YES, WE CAN SEND YOU A SAMPLE, HOW MANY PIECES WOULD YOU LIKE US TO SEND YOU? ¿ WHERE WAS THE FOREIGN MATTER LOCATED? INSIDE THE FLUID PATH OR OUTSIDE ON THE SURFACE OF THE PRODUCT? IT LOOKS LIKE THE FOREIGN MATERIAL IS MIXED WITH THE MAIN MATERIAL ¿ CAN YOU IDENTIFY THE FOREIGN MATTER? NO, IT¿S NOT POSSIBLE FOR US TO IDENTIFY THE FOREIGN MATERIAL ¿ IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC / NEEDLE? IT¿S EMBEDDED IN THE PLASTIC
MATERIAL#: 1023-130-071 BATCH#: 3059001 IT WAS REPORTED BY THE CUSTOMER THAT DURING THE INCOMING INSPECTION OF MATERIAL R-90117-001 LOT 13P23G0018 QTY 100,000 EA, IT WAS DETECTED THAT THE MATERIAL CONTAINED FOREIGN MATERIAL. SAMPLE OF (B)(4) EA, REJECT WITH 8 EA AND 61 EA WERE FOUND WITH THIS DEFECT. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED. INCOMING INSPECTION AT XXX OPENED A NC DUE TO A CONNECTOR (PN 1023-130-071) THAT WAS FOUND WITH FOREIGN MATERIAL ATTACHED YOU CAN FIND THE FRM-001621 ¿SUPPLIER NON-CONFORMANCE NOTIFICATION¿ WITH MORE DETAILS ABOUT THIS NC: ON JULY 7 2023, AT XXX PLANT, DURING THE INCOMING INSPECTION OF MATERIAL R-90117-001 LOT 13P23G0018 QTY (B)(4) EA, IT WAS DETECTED THAT THE MATERIAL CONTAINED FOREIGN MATERIAL. SAMPLE OF (B)(4). EA, REJECT WITH 8 EA AND 61 EA WERE FOUND WITH THIS DEFECT. COULD YOU PLEASE HELP US WITH AN INVESTIGATION AND THE MATERIAL DISPOSITION? XXX PN: R-90117-001 SUPPLIER PN: 1023-130-071 XXX BATCH: 13P23G0018 SUPPLIER BATCH: 3059001 PO: 6502073752 QTY: (B)(4). RESPONSE RECEIVED ON 19-JUL-2023. ¿ IS THERE SAMPLE AVAILABLE TO RETURN FOR EVALUATION? IF YES, CAN YOU PROVIDE FACILITY ADDRESS FOR US TO GENERATE FEDEX LABEL? YES, WE CAN SEND YOU A SAMPLE, HOW MANY PIECES WOULD YOU LIKE US TO SEND YOU? ¿ WHERE WAS THE FOREIGN MATTER LOCATED? INSIDE THE FLUID PATH OR OUTSIDE ON THE SURFACE OF THE PRODUCT? IT LOOKS LIKE THE FOREIGN MATERIAL IS MIXED WITH THE MAIN MATERIAL ¿ CAN YOU IDENTIFY THE FOREIGN MATTER? NO, IT¿S NOT POSSIBLE FOR US TO IDENTIFY THE FOREIGN MATERIAL ¿ IS THE FOREIGN MATTER ABLE TO BE REMOVED OR IS IT EMBEDDED IN THE PLASTIC / NEEDLE? IT¿S EMBEDDED IN THE PLASTIC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 740570 | BD FEMALE LUER LOK ADAPTER | INTRAVASCULAR ADMINISTRATION SET | FPA | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 3059001 | 70885403484263 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |