BD LUER-LOK
Report
- Report Number
- 1213809-2025-00673
- Event Type
- Malfunction
- Date Received
- October 24, 2025
- Date of Event
- September 29, 2025
- Report Date
- October 31, 2025
- Manufacturer
- BECTON DICKINSON MEDICAL SYSTEMS
- Product Code
- FMF
- UDI-DI
- 00382903029952
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
INVESTIGATION RESULTS: SINCE NO SAMPLES DISPLAYING THE REPORTED CONDITION WERE RECEIVED A POTENTIAL ROOT CAUSE COULD NOT BE DEFINED AND CORRECTIVE ACTIONS ARE NOT NECESSARY. A PHYSICAL SAMPLE IS REQUIRED FOR A MORE THOROUGH EVALUATION AND POTENTIAL ROOT CAUSE DETERMINATION. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. BATCH 5097483 IS CONSIDERED IN COMPLIANCE WITH OUR PRODUCT SPECIFICATION REQUIREMENTS.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
NO ADDITIONAL INFORMATION.
IT WAS REPORTED THAT THE BD SYRINGE 10ML LL S/C 200 PLUNGER ROD WAS BROKEN / DAMAGED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL # 302995 BATCH # 5097483. RCC RECEIVED A COMPLAINT VIA EMAIL. PRODUCT INFORMATION PRODUCT CODE: 302995 PRODUCT DESCRIPTION: SYRINGE HYPO 10CC L/L BX/200 LOT/SERIAL #:(B)(6) EXPIRY DATE: N/A. PROBLEM INFORMATION PLEASE CITE CUSTOMER COMPLAINT # (B)(4) PLUNGER BENDS AND THE MEDICINE LEAKS OUT OF THE BOTTOM OF THE SYRINGE. DOCTOR ALSO HAD THE SAME ISSUE IN THE PEDIATRIC DAY UNIT. OCCURRENCES: 3 EACHES. SAMPLE INFORMATION INCIDENT SAMPLES: 0 REPRESENTATIVE SAMPLES: 0. NO ADVERSE EVENT REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1504031 | BD LUER-LOK | PISTON SYRINGE | FMF | BECTON DICKINSON MEDICAL SYSTEMS | 5097483 | 00382903029952 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |