BD LUER-LOK
Report
- Report Number
- 1213809-2024-00998
- Event Type
- Malfunction
- Date Received
- December 29, 2024
- Date of Event
- December 3, 2024
- Report Date
- March 17, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 30382903096054
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
D.4. OTHER LOT NUMBER INCLUDES 4110189 AND OTHER EXPIRATION DATE INCLUDES 2029-03-31. H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. H.4. OTHER LOT NUMBER DEVICE MANUFACTURE DATE IS 2024-04-19.
BECTON DICKINSON AND COMPANY'S (BD) MEDICATION DELIVERY SOLUTIONS (MDS) BUSINESS UNIT WILL DISCONTINUE MALFUNCTION MDR REPORTING FOR CERTAIN DEVICE FAILURES THAT HAVE NOT CAUSED OR CONTRIBUTED TO DEATHS OR SERIOUS INJURIES IN THE PAST TWO YEARS, AND WHERE THE LIKELIHOOD OF A DEATH OR SERIOUS INJURY AS A RESULT OF THESE MALFUNCTIONS IS REMOTE. THIS DECISION FOLLOWS FDA GUIDELINES (MEDICAL DEVICE REPORTING FOR MANUFACTURERS GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF ISSUED NOV 8, 2016, REFERENCE SECTION 2.15). BD NOTIFIED FDA OF THIS DECISION ON MAR 3, 2025. FDA HAS REVIEWED AND RESPONDED TO BD¿S NOTIFICATION (REFERENCE FDA DOCUMENT # GEN2500107) ON MARCH 7, 2025. THIS DOCUMENTATION IS AVAILABLE IN BD DOCUMENT MANAGEMENT SYSTEM (SAP) AS DIR (B)(4). THIS SUPPLEMENTAL MDR IS BEING FILED TO DOCUMENT THAT THE BELOW DEVICE FAILURE WILL NO LONGER BE CONSIDERED A REPORTABLE MALFUNCTION MDR FOR THE PRODUCT FAMILY BELOW: PRODUCT FAMILY: CONVENIENCE TRAYS DEVICE FAILURE: SCALE MARKING ISSUE.
ONE SAMPLE AND TWO PHOTOS WERE PROVIDED TO OUR QUALITY TEAM FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT WAS OBSERVED THAT THE SAMPLE HAS A SKEWED SCALE MARKING. THE CONDITION OBSERVED IS NON-CONFORMING PER PRODUCT SPECIFICATION. THE POTENTIAL ROOT CAUSE FOR THE SKEWED SCALE DEFECT IS ASSOCIATED WITH THE MARKING PROCESS. THESE CONDITIONS ARE OCCURRING BELOW THEIR EXPECTED FREQUENCY, SO NO CORRECTIVE ACTION IS REQUIRED AT THIS TIME. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED LOT NUMBER 4110189 AND 4088616. 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.
MATERIAL#: 309605 BATCH NUMBER#: 4110189, 4088616 IT WAS REPORTED THAT THE BD LUER-LOK HAD SCALE MARKING ISSUES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: VERBATIM#: RCC RECEIVED A COMPLAINT VIA EMAIL. EMAIL(S) ATTACHED PRINTING DEFECT - NUMEROUS SYRINGES POTENTIAL LOT# 4110189, 4088616 PRODUCT NUMBER - 309605 ADDITIONAL INFORMATION PROVIDED: 1. WHAT IS THE DATE OF EVENT? DEC 3, 2024 2. DID THE PRODUCT UNKNOWINGLY USED ON PATIENT. IF YES, PLEASE DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT INVOLVEMENT. 3. YOU HAVE MENTIONED TOTAL OF 238 DEFECTS. PLEASE MENTION THE QUANTITY FOR TWO LOTS. IT IS UNKNOWN THE LOT # OF THE DEFECTS. TWO LOTS OF SYRINGES WERE USED IN THIS COMPOUNDED BATCH.
NO ADDITIONAL INFORMATION.
NO ADDITIONAL INFORMATION WAS PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2494914 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 4088616 | 30382903096054 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |