BD LUER-LOK
Report
- Report Number
- 1911916-2025-00704
- Event Type
- Malfunction
- Date Received
- October 28, 2025
- Date of Event
- September 3, 2025
- Report Date
- November 7, 2025
- Manufacturer
- BD MEDICAL (BD WEST) MEDICAL SURGICAL
- Product Code
- FMF
- UDI-DI
- 00382903096534
- PMA / PMN Number
- K110771
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NH, US
- Reporter Occupation
- 003
Narratives
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED.
ADDITIONAL INFORMATION: (H) ATTACHED MEDWATCH INVESTIGATION RESULTS: BASED ON THE INVESTIGATION AND WITH NO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER COULD NOT BE CONFIRMED. WE WILL CONTINUE MONITORING THE COMPLAINT TREND FOR THE PRODUCT AND SYMPTOM. WITH NO ACTUAL SAMPLE ANALYSIS, A PROBABLE ROOT CAUSE COULD NOT BE OFFERED.
IT WAS REPORTED THAT THE BD SYRINGE 60ML LL TIP 1ML LUER WAS CRACKED / DAMAGED / DEFORMED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: MATERIAL#: 309653, BATCH#: 5142417. RCC RECEIVED A COMPLAINT VIA EMAIL. WHILE PERFORMING THERAPEUTIC PHLEBOTOMY VIA VAD, WHEN NURSING REMOVED A 50ML LUER LOCK SYRINGE FROM LARGE BORE STOPCOCK WITH ROTATING MALE LUER LOCK(BARD) THE TIP OF THE LUER LOCK OF THE 50ML SYRINGE HAD SEVERED/BROKEN. NURSING REMOVED ALL EQUIPMENT FROM PATIENT. ATTACHED SYRINGE DIRECTLY TO VAD ASPIRATED/DISCARDED 10ML BLOOD AND FLUSHED VAD WITHOUT INCIDENT. NO INJURY TO PATIENT. LOT#: 5142417.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 234081 | BD LUER-LOK | PISTON SYRINGE | FMF | BD MEDICAL (BD WEST) MEDICAL SURGICAL | 5142417 | 00382903096534 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Male |