BD SYRINGE 1ML LL BNS
Report
- Report Number
- 1213809-2025-00211
- Event Type
- Malfunction
- Date Received
- March 19, 2025
- Date of Event
- March 6, 2025
- Report Date
- June 12, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 50382903096485
- PMA / PMN Number
- NA
- 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 - FOREIGN MATTER. ONE PHOTO WAS PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS TWO LOOSE SYRINGES WITH BROWN DISCOLORATION ON THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4243174. 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.
(B)(4). SUPPLEMENTAL MDR - FOREIGN MATTER. SIX SAMPLES AND ONE PHOTO WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THE PHOTO SHOWS TWO LOOSE SYRINGES WITH BROWN DISCOLORATION ON THE BARREL CONSISTENT WITH EMBEDDED FOREIGN MATTER. ALL SIX SYRINGES WERE RECEIVED LOOSE; FOUR WERE FOUND TO BE FREE OF DEFECTS, WHILE TWO EXHIBITED THE BROWN DISCOLORATION AS DESCRIBED. THE OBSERVED CONDITION IS NON-CONFORMING PER PRODUCT SPECIFICATIONS. POTENTIAL ROOT CAUSE FOR THE EMBEDDED FOREIGN MATTER DEFECT IS ASSOCIATED WITH THE MOLDING PROCESS. THE EMBEDDED FOREIGN MATTER IS MOST LIKELY DEGRADED PLASTIC. THIS OCCURS WHEN THE RESIN IS EXPOSED TO PROLONGED HIGH TEMPERATURES INSIDE THE MOLDING MACHINE, SUCH AS DURING START-UP. THIS TYPE OF DEFECT IS COSMETIC AND DOES NOT POSE A RISK TO THE CUSTOMER. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4243174. A REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION 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.
B.3. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO ADDITIONAL INFORMATION WAS PROVIDED.
NO ADDITIONAL INFORMATION WAS PROVIDED.
MATERIAL #306584 LOT #UNKNOWN. IT WAS REPORTED THAT THE BD SYRINGE 1ML LL BNS HAD FOREIGN MATTER. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT DIRTY PARTS. RCC RECEIVED A COMPLAINT VIA EMAIL. PART NUMBER C3301, LOT NUMBER(S) 302452 & 306584, ISSUE DESCRIPTION DIRTY PARTS. ARE SAMPLES AVAILABLE FOR EVALUATION IF NEEDED? YES APPLICATION IS THIS THE FIRST TIME YOU ARE USING THIS PRODUCT IN YOUR APPLICATION? NO WAS THE ISSUE OBSERVED DURING INCOMING INSPECTION/BEFORE USE? YES IF THE ISSUE WAS OBSERVED DURING USE, WHAT CHEMICALS/FLUID WAS THE PART WAS EXPOSED TO? NOTES: SDS MUST BE PROVIDED WITH THE SAMPLES THE PART BEING RETURNED MUST BE APPROPRIATELY DECONTAMINATED BEFORE BEING RETURNED TO US. WHAT STERILIZATION METHOD WAS THE PART EXPOSED TO? NONE WHAT TEMPERATURE WAS THE PART EXPOSED TO? NONE WHAT PRESSURE WAS THE PART EXPOSED TO? NONE QOSINA LOT 302452 = VENDOR LOT 4135962 QOSINA LOT 306584 = VENDOR LOT 4243174 WE ARE CURRENTLY CHECKING OUR STOCK. PLEASE LET ME KNOW IF YOU NEED SAMPLES OR IF THE IMAGES BELOW AND PROVIDED CASE DETAILS SUFFICE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1372732 | BD SYRINGE 1ML LL BNS | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 4243174 | 50382903096485 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |