BD LUER-LOK
Report
- Report Number
- 1213809-2024-00384
- Event Type
- Malfunction
- Date Received
- June 18, 2024
- Date of Event
- April 30, 2024
- Report Date
- August 16, 2024
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096283
- PMA / PMN Number
- K941562
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
PR (B)(4) SUPPLEMENTAL MDR FOLLOW UP FOR CORRECTED DEVICE EVALUATION ONE SAMPLE AND THREE PHOTOS OF A 1ML LUER-LOK SYRINGE WAS RECEIVED AND EVALUATED. THE SAMPLE WAS RECEIVED LOOSE WITH A NEEDLE IDENTIFIED TO BE MATERIAL NUMBER 305211, LOT 3145373. THE NEEDLE WAS FOUND TO BE CLOGGED AND WOULD NOT DRAW UP FLUID INTO THE SYRINGE WHEN ATTACHED. THE SYRINGE WITHOUT THE NEEDLE ATTACHED DREW UP FLUID. ALL THREE PHOTOS SHOW A LOOSE SYRINGE WITH UNKNOWN RED NEEDLE ATTACHED. ONE IMAGE SHOWS AIR BUBBLES IN THE HUB OF THE NEEDLE. THE NEEDLE IS NOT INCLUDED IN THE PACKAGING OF THIS SYRINGE. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR CLOGGED NEEDLE DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE SAMPLES AND PHOTOS HAVE BEEN EVALUATED BY THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3122725 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. WE APPRECIATE YOU TAKING THE TIME TO BRING THIS OBSERVATION TO OUR ATTENTION. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED MONTHLY. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
ONE SAMPLE AND THREE PHOTOS OF A 1ML LUER-LOK SYRINGE WAS RECEIVED AND EVALUATED. THE SAMPLE WAS RECEIVED LOOSE WITH AN UNKNOWN NEEDLE INCLUDED. THE NEEDLE WAS FOUND TO BE CLOGGED AND WOULD NOT DRAW UP FLUID INTO THE SYRINGE WHEN ATTACHED. THE SYRINGE WITHOUT THE NEEDLE ATTACHED DREW UP FLUID. ALL THREE PHOTOS SHOW A LOOSE SYRINGE WITH UNKNOWN RED NEEDLE ATTACHED. ONE IMAGE SHOWS AIR BUBBLES IN THE HUB OF THE NEEDLE. THE NEEDLE IS NOT INCLUDED IN THE PACKAGING OF THIS SYRINGE. THE CONDITION OBSERVED IS ACCEPTABLE PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR CLOGGED NEEDLE DEFECT IS ASSOCIATED WITH THE NEEDLE SUPPLIER¿S MANUFACTURING PROCESS. THE SAMPLES AND PHOTOS HAVE BEEN EVALUATED BY THE NEEDLE SUPPLIER FOR FURTHER EVALUATION AND INVESTIGATION. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 3122725 SHOWING NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
NO ADDITIONAL INFORMATION WAS PROVIDED.
MATERIAL# 309628 BATCH# 3122725 IT WAS REPORTED THAT THE BD LUER-LOK HAD LEAKAGE AT THE LUER CONNECTION. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ON 02-MAY-2024, REGENERON MEDICAL INFORMATION RECEIVED A REQUEST VIA PHONE FROM AN HCP'S OFFICE FOR THE RETURN/REPLACEMENT OF 1 EYLEA HD KIT DUE TO MEDICATION LEAKING FROM THE SYRINGE DURING WITHDRAWAL. ON 30-APR-2024, THE TECHNICIAN WAS PREPARING THE PRODUCT FOR ADMINISTRATION AND HAD WITHDRAWN THE MEDICATION OUT OF THE VIAL WITH THE FILTER NEEDLE. WHILE ATTEMPTING TO PUSH OUT THE MEDICATION AND AIR BUBBLES FROM THE SYRINGE, THE TECHNICIAN NOTICED THAT THE MEDICATION WAS BUBBLING OUT AT THE JUNCTION WHERE THE FILTER NEEDLE IS ATTACHED TO THE SYRINGE. THE OFFICE CONFIRMED THAT THE FILTER NEEDLE WAS ATTACHED FIRMLY TO THE SYRINGE AND STATED THAT "MAYBE THE SYRINGE WAS CRACKED?" MEDICAL INFORMATION INQUIRED FURTHER ABOUT THE SYRINGE BEING CRACKED AND THE REPORTER STATED THAT SHE DID NOT NOTE AND CRACKS OR DAMAGE TO THE SYRINGE. THE REPORTER STATED NO PATIENTS MISSED A DOSE DUE TO THIS EVENT AND DENIED ANY ADVERSE EVENTS. THE REPORTER HAD THE PRODUCT AVAILABLE FOR RETURN AND WAS INSTRUCTED TO RETAIN THE PRODUCT FOR RETRIEVAL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. 1. COULD YOU PROVIDE A PHOTOGRAPH THAT INCLUDES THE LOT NUMBER? YES A. IF YES, WOULD YOU PLEASE SEND IT TO PRODUCT. [email protected] 2. WERE NON-SUPPLIED COMPONENTS USED IN PREPARING/ADMINISTERING THE DOSE? NO A. IF YES, WHAT WAS USED? (BRAND & ITEM #) 3. WAS THE TAMPER EVIDENT SEAL PRESENT ON THE CARTON? YES 4. WAS THE TAMPER EVIDENT SEAL INTACT WHEN THE PRODUCT CARTON WAS RECEIVED? YES 5. WAS THE SHIPPING CONTAINER DAMAGED? NO A. IF YES, WHAT PART OF THE SHIPPING CONTAINER WAS DAMAGED? 6. WAS THE PRODUCT CARTON DAMAGED? NO A. IF YES, WHAT PART OF THE CARTON WAS DAMAGED? 7. SPECIFY WHICH COMPONENT WAS DAMAGED: SYRINGE 8. WAS THE DAMAGED NOTED: DURING WITHDRAWAL FROM THE VIAL BD SYRINGE LOT: 3122725 BD FILTER NEEDLE LOT: 3145373.
MATERIAL# 309628, BATCH# 3122725. IT WAS REPORTED BY CUSTOMER THAT THE BUBBLING OUT AT THE JUNCTION WHERE THE FILTER NEEDLE IS ATTACHED TO THE SYRINGE. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. ON 02-MAY-2024, REGENERON MEDICAL INFORMATION RECEIVED A REQUEST VIA PHONE FROM AN HCP'S OFFICE FOR THE RETURN/REPLACEMENT OF 1 EYLEA HD KIT DUE TO MEDICATION LEAKING FROM THE SYRINGE DURING WITHDRAWAL. ON 30-APR-2024, THE TECHNICIAN WAS PREPARING THE PRODUCT FOR ADMINISTRATION AND HAD WITHDRAWN THE MEDICATION OUT OF THE VIAL WITH THE FILTER NEEDLE. WHILE ATTEMPTING TO PUSH OUT THE MEDICATION AND AIR BUBBLES FROM THE SYRINGE, THE TECHNICIAN NOTICED THAT THE MEDICATION WAS BUBBLING OUT AT THE JUNCTION WHERE THE FILTER NEEDLE IS ATTACHED TO THE SYRINGE. THE OFFICE CONFIRMED THAT THE FILTER NEEDLE WAS ATTACHED FIRMLY TO THE SYRINGE AND STATED THAT "MAYBE THE SYRINGE WAS CRACKED?" MEDICAL INFORMATION INQUIRED FURTHER ABOUT THE SYRINGE BEING CRACKED AND THE REPORTER STATED THAT SHE DID NOT NOTE AND CRACKS OR DAMAGE TO THE SYRINGE. THE REPORTER STATED NO PATIENTS MISSED A DOSE DUE TO THIS EVENT AND DENIED ANY ADVERSE EVENTS. THE REPORTER HAD THE PRODUCT AVAILABLE FOR RETURN AND WAS INSTRUCTED TO RETAIN THE PRODUCT FOR RETRIEVAL. NO ADDITIONAL INFORMATION WAS AVAILABLE AT THE TIME OF THIS REPORT. 1. COULD YOU PROVIDE A PHOTOGRAPH THAT INCLUDES THE LOT NUMBER? YES A. IF YES, WOULD YOU PLEASE SEND IT TO [email protected]. 2. WERE NON-SUPPLIED COMPONENTS USED IN PREPARING/ADMINISTERING THE DOSE? NO A. IF YES, WHAT WAS USED? (BRAND & ITEM #). 3. WAS THE TAMPER EVIDENT SEAL PRESENT ON THE CARTON? YES. 4. WAS THE TAMPER EVIDENT SEAL INTACT WHEN THE PRODUCT CARTON WAS RECEIVED? YES. 5. WAS THE SHIPPING CONTAINER DAMAGED? NO A. IF YES, WHAT PART OF THE SHIPPING CONTAINER WAS DAMAGED? 6. WAS THE PRODUCT CARTON DAMAGED? NO A. IF YES, WHAT PART OF THE CARTON WAS DAMAGED? 7. SPECIFY WHICH COMPONENT WAS DAMAGED: SYRINGE 8. WAS THE DAMAGED NOTED: DURING WITHDRAWAL FROM THE VIAL. BD SYRINGE LOT: 3122725. BD FILTER NEEDLE LOT: 3145373.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 938679 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 3122725 | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |