BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK
Report
- Report Number
- 9610847-2024-00128
- Event Type
- Malfunction
- Date Received
- May 16, 2024
- Date of Event
- April 25, 2024
- Report Date
- November 19, 2024
- Manufacturer
- BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
- Product Code
- FMF
- UDI-DI
- 30382903097020
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 6 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT A PARTICLE COULD BE OBSERVED IN THE BARREL OF THE SYRINGE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED WITH THE ASSEMBLY PROCESS. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS.
IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD.
INVESTIGATION RESULTS: OUR QUALITY ENGINEER INSPECTED THE 6 PHOTOS AND 1 PHYSICAL SAMPLE SUBMITTED FOR EVALUATION. THE REPORTED ISSUE OF FOREIGN MATTER WAS CONFIRMED UPON INSPECTION AND TESTING OF THE SAMPLES. ANALYSIS OF THE SAMPLE SHOWED THAT A PARTICLE COULD BE OBSERVED IN THE BARREL OF THE SYRINGE. BD DETERMINED THAT THE CAUSE OF THE FAILURE WAS ASSOCIATED WITH THE ASSEMBLY PROCESS. A RETRAINING OF MANUFACTURING PERSONNEL WAS PERFORMED TO ADDRESS THIS ISSUE. A REVIEW OF OUR RISK MANAGEMENT DOCUMENTATION WAS PERFORMED AND INDICATES THAT THE POTENTIAL RISK OF THE REPORTED EVENT WAS ASSESSED APPROPRIATELY. PRODUCTION RECORDS WERE REVIEWED, AND THIS BATCH MEETS OUR MANUFACTURING SPECIFICATION REQUIREMENTS. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT BD BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK HAD FOREIGN MATTER IT WAS REPORTED BY CUSTOMER THAT THEY HAVE IDENTIFIED ATYPICAL PARTICULATES, ONE OF THE RESULTS WE HAVE RECEIVED HAS ID THE PARTICULATE AS FIBERGLASS. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. PER END USER, THEY WOULD LIKE TO INITIATE A PRODUCT COMPLAINT FOR MFR# (B)(4) BD 3ML SYR TRAY VENDOR LOT 3212551 AND 3212547. THEY HAVE IDENTIFIED ATYPICAL PARTICULATES, ONE OF THE RESULTS WE HAVE RECEIVED HAS ID THE PARTICULATE AS FIBERGLASS. PLEASE PROVIDE CREDIT AND OR ADVISE IF A RETURN IS NEEDED FOR 371 TR/MFR# (B)(4).
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 925063 | BD SYRINGE 3ML LL TIP BULK CONVENIENCE PAK | SYRINGE | FMF | BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. | 3212547 | 30382903097020 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |