NEEDLE 18X1-1/2 RB
Report
- Report Number
- 1911916-2025-00128
- Event Type
- Malfunction
- Date Received
- February 19, 2025
- Date of Event
- February 13, 2025
- Report Date
- March 12, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- FMI
- UDI-DI
- 30382903051961
- PMA / PMN Number
- K021475
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.
(B)(4) FOLLOW UP FOR DEVICE EVALUATION IT WAS REPORTED THERE IS RESIDUE THAT POPS OFF DURING USE. TO AID IN THE INVESTIGATION, SIXTY-FIVE SAMPLES IN SEALED PACKAGING BLISTERS AND TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. A VISUAL INSPECTION WAS PERFORMED. SIX OF THE SAMPLES HAVE AN EPOXY DRIP OVER ON THE NEEDLE HUB. NO OTHER DEFECTS OR IMPERFECTIONS WERE OBSERVED. ONE PHOTO SHOWS A NEEDLE ASSEMBLY IN A PACKAGING BLISTER; THE NEEDLE HUB HAS AN EPOXY DRIP OVER. THE SECOND PHOTO SHOWS A WHITE PARTICLE ON A DARK COLORED SURFACE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. THE EPOXY ON THE NEEDLE HUB OCCURS DURING THE ASSEMBLY PROCESS WHEN THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4212625. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION WITH THE RETURNED SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.
(B)(4).FOLLOW UP : IT WAS REPORTED THERE IS RESIDUE THAT POPS OFF DURING USE. AS A SAMPLE WAS NOT RETURNED, A THOROUGH SAMPLE EVALUATION COULD NOT BE PERFORMED. TO AID IN THE INVESTIGATION, TWO PHOTOS WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. ONE PHOTO SHOWS A NEEDLE ASSEMBLY IN A PACKAGING BLISTER; THE NEEDLE HUB HAS AN EPOXY DRIP OVER. THE SECOND PHOTO SHOWS A WHITE PARTICLE ON A DARK COLORED SURFACE. NO OTHER INFORMATION COULD BE OBTAINED FROM THE PHOTOS. THE EPOXY ON THE NEEDLE HUB OCCURS DURING THE ASSEMBLY PROCESS WHEN THERE IS A JAM AT THE CANNULATOR. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED FOR PROVIDED MATERIAL NUMBER 305196, LOT 4212625. THE REVIEW DID NOT REVEAL ANY DETECTED QUALITY ISSUES DURING THE PRODUCTION OF THIS LOT THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT. THERE WERE NO RELATED QUALITY NOTIFICATIONS. ALL PROCESSES AND FINAL INSPECTIONS COMPLIED WITH SPECIFICATION REQUIREMENTS. VERIFICATION OF THE CANNULATOR WAS PERFORMED. THE SETTINGS WERE CORRECT, AND THE FLOW OF PRODUCT WAS GOOD. TO DATE, THERE HAVE BEEN NO OTHER SIMILAR EVENTS REPORTED FOR THIS LOT. BASED ON THE INVESTIGATION AND WITH THE PHOTO SAMPLE ANALYSIS THE SYMPTOM REPORTED BY THE CUSTOMER IS CONFIRMED.
MATERIAL # 305196. BATCH # 4212625. VERBATIM: RCC RECEIVED A COMPLAINT VIA EMAIL. WE HAVE 6 BOXES OF NEEDLES SEQUESTERED. THEY APPEAR TO HAVE A RESIDUE THAT POPS OFF DURING USE. CUSTOMER RESPONSE ON (B)(6)2025. 1. CAN YOU PLEASE PROVIDE AN EXACT DATE OF EVENT? NOTICED ANOMALY ON 2-13-2025 - SEQUESTERED INVENTORY. 2. CAN YOU PLEASE PROVIDE THE LOT NUMBER ASSOCIATED WITH REPORTED ISSUE? 4212625. 3. ANY ADVERSE EVENT OR SERIOUS INJURY REPORTED TO PATIENT OR HEALTHCARE PROFESSIONAL? IF YES, PLEASE PROVIDE THE DETAILS. UNKNOWN.
NO ADDITIONAL INFORMATION RECEIVED.
NO ADDITIONAL INFORMATION RECEIVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2641662 | NEEDLE 18X1-1/2 RB | NEEDLE, HYPODERMIC, SINGLE LUMEN | FMI | BECTON DICKINSON | 4212625 | 30382903051961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |