LUER-LOK
Report
- Report Number
- 1213809-2025-00303
- Event Type
- Malfunction
- Date Received
- April 24, 2025
- Date of Event
- January 15, 2025
- Report Date
- August 26, 2025
- 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
(B)(4) - SUPPLEMENTAL MDR/CORRECTION - FOREIGN MATTER. CORRECTION: FOLLOWING SUBMISSION OF INITIAL MDR, LOT NUMBER WAS CHANGED TO UNKNOWN. A POTENTIAL LOT NUMBER WAS PROVIDED. LOT 4054302 EXP DATE: 2029-JAN-31, 3122722 EXP DATE: 2028-APR-30, 3285677 EXP DATE: 2028-SEP-30, 3291217 EXP DATE: 2028-SEP-30. EVALUATION: IT WAS REPORTED A GREEN PARTICLE WAS OBSERVED IN THE PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. AS A PHYSICAL SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, FOUR PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. TWO IMAGES SHOWED THE SYRINGE BARREL TIP CONNECTED TO AN UNKNOWN NEEDLE WITH A SMALL GREEN PARTICULATE VISIBLE IN THE NEEDLE HUB AREA, ONE IMAGE DISPLAYED THE PARTICULATE IN A LOOSE STATE, AND THE FINAL IMAGE PRESENTED FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS OF THE PARTICULATE. AS THIS PRODUCT IS SOLD WITHOUT A NEEDLE INCLUDED, NO CORRECTIVE ACTIONS ARE REQUIRED FROM THE SYRINGE MANUFACTURING PLANT. 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.
(B)(4)- SUPPLEMENTAL MDR - FOREIGN MATTER IT WAS REPORTED A GREEN PARTICLE WAS OBSERVED IN THE PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE, A GLASS PLATE CONTAINING A GREEN-COLORED PARTICLE, AND THREE PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. TWO IMAGES SHOWED THE SYRINGE BARREL TIP CONNECTED TO AN UNKNOWN NEEDLE WITH A SMALL GREEN PARTICULATE VISIBLE IN THE NEEDLE HUB AREA, ONE IMAGE DISPLAYED THE PARTICULATE IN A LOOSE STATE, AND THE FINAL IMAGE PRESENTED FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS OF THE PARTICULATE. AS THIS PRODUCT IS SOLD WITHOUT A NEEDLE INCLUDED, NO CORRECTIVE ACTIONS ARE REQUIRED FROM THE SYRINGE MANUFACTURING PLANT. 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.
PR 11894035 - SUPPLEMENTAL MDR - FOREIGN MATTER. IT WAS REPORTED THAT A GREEN PARTICLE WAS OBSERVED IN THE PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. TO SUPPORT THE INVESTIGATION, ONE UNPACKAGED SAMPLE, A GLASS PLATE CONTAINING A GREEN-COLORED PARTICLE, AND FOUR PHOTOGRAPHS WERE SUBMITTED FOR EVALUATION. ALTHOUGH FOUR SYRINGE LOT NUMBERS WERE SPECIFIED IN THE COMPLAINT, ONLY ONE SYRINGE OF UNKNOWN LOT WAS RETURNED. TWO IMAGES SHOWED THE SYRINGE BARREL TIP CONNECTED TO AN UNKNOWN NEEDLE WITH A SMALL GREEN PARTICULATE VISIBLE IN THE NEEDLE HUB AREA, ONE IMAGE DISPLAYED THE PARTICULATE IN A LOOSE STATE, AND THE FINAL IMAGE PRESENTED FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS OF THE PARTICULATE WHICH IDENTIFIED THE FOREIGN MATERIAL AS A SYNTHETIC PLASTIC. THE FOREIGN MATTER WAS VISUALLY EVALUATED, AND THE FOURIER TRANSFORM INFRARED SPECTROSCOPY (FTIR) ANALYSIS WAS COMPARED WITH KNOWN SOURCES WITHIN BD. THE ANALYSIS CONFIRMED TO HAVE NOT ORIGINATED FROM BD¿S SYRINGE MANUFACTURING PROCESS. AS THIS PRODUCT IS SOLD WITHOUT A NEEDLE INCLUDED, NO CORRECTIVE ACTIONS ARE REQUIRED FROM THE SYRINGE MANUFACTURING PLANT. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBERS 4054302, 3122722, 3285677, 3291217. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. 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.
NO ADDITIONAL INFORMATION WAS PROVIDED.
IT WAS REPORTED THAT THE BD SYRINGE 1ML LL HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309628, BATCH#: 4054302. RCC RECEIVED A COMPLAINT VIA EMAIL. ON 15JAN2025, WAS INFORMED OF AN EVENT WITH EYLEA 8MG VIAL KIT WHICH WAS CATEGORIZED WITH THE DEFECT FOREIGN MATTER FM- SYRINGE. ON 27JAN2025, ONE SYRINGE RETURNED WITH GREEN PARTICLE OBSERVED IN PRODUCT FLOW PATH WITHIN THE NEEDLE HUB CONNECTION. FILTER NEEDLE: CATALOG: 305211, LOT: 4031348, 1 ML SYRINGE, CATALOG: 309628, LOT: 4054302, INJECTION NEEDLE, CATALOG: 305106, LOT: 3334821. CUSTOMER RESPONDED ON 21-APR. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT IN FORMAT MM-DD-YYYY? 15JAN2025. 2. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. N/A. 3. COULD YOU PLEASE CONFIRM IF THERE ARE ANY SAMPLES AVAILABLE TO SEND TO BD FOR INVESTIGATION? SAMPLE WILL NOT BE FORWARDED AT THIS TIME.
NO ADDITIONAL INFORMATION WAS PROVIDED.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1275575 | LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | UNKNOWN | 30382903096283 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |