NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE
Report
- Report Number
- 2243072-2025-00946
- Event Type
- Malfunction
- Date Received
- August 5, 2025
- Date of Event
- June 12, 2025
- Report Date
- September 3, 2025
- Manufacturer
- BECTON DICKINSON
- Product Code
- BSP
- UDI-DI
- 00382904051808
- PMA / PMN Number
- K210978
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
FOLLOW UP MDR FOR ADDITIONAL INFORMATION. SEE B TAB. CORRECTION: SEE D TAB. MANUFACTURING LOCATION: BD CARIBE. 510K: K210978. ANNEX F CODE UPDATED.
H.3. IF A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS COMPLETED, A SUPPLEMENTAL REPORT WILL BE FILED. UNKNOWN MANUFACTURER: THERE ARE MULTIPLE BD LOCATIONS WHERE THIS UNSPECIFIED BD DEVICE MAY HAVE BEEN MANUFACTURED. A CATALOG AND LOT NUMBER COULD NOT BE CONFIRMED FOR THIS INCIDENT AND WITHOUT THIS INFORMATION WE ARE UNABLE TO DETERMINE WHERE THE DEVICE WAS MANUFACTURED. THEREFORE, BD CORPORATE HEADQUARTERS IN FRANKLIN LAKES, NJ HAS BEEN LISTED IN SECTIONS D.3. AND G.1. AND THE FRANKLIN LAKES FDA REGISTRATION NUMBER HAS BEEN USED FOR THE MANUFACTURE REPORT NUMBER.
SINCE NO SAMPLES DISPLAYING THE CONDITION REPORTED ARE AVAILABLE FOR EXAMINATION, WE WERE UNABLE TO FULLY INVESTIGATE THIS INCIDENT, THEREFORE A ROOT CAUSE COULD NOT BE DETERMINED. FURTHERMORE, A DEVICE HISTORY RECORD REVIEW SHOWED NO REJECTED INSPECTIONS OR QUALITY ISSUES DURING THE PRODUCTION OF THE PROVIDED LOT NUMBER THAT COULD HAVE CONTRIBUTED TO THE REPORTED DEFECT.
ADDITIONAL INFORMATION 1. AS MENTIONED, THERE ARE TWO MORE INCIDENTS RELATED TO LEAKAGE. COULD YOU PLEASE PROVIDE THE EXACT DATES OF THESE EVENTS IN THE MM-DD-YYYY FORMAT? (B)(6) 2025. 2. PLEASE SHARE THE MATERIAL & LOT NUMBER ASSOCIATED WITH REPORTED ISSUE LOT # IS THE SAME FOR BOTH DATES. CAME FROM THE SAME BOX. 4267390. SKU# 405180. BD 25G X 3.5" QUINCKE SPINAL NEEDLES. 3. DESCRIBE ANY PATIENT HARM, INJURY, COMPLICATION OR NEGATIVE OUTCOME THAT OCCURRED AS A RESULT OF THE EVENT. NO PATIENT HARM/INJURY. COMPLICATION/NEGATIVE OUTCOME IS THAT THE WITH THE LEAKING HUB AREA, THE PROVIDER FEELS THAT THE FULL DOSAGE OF THE MEDICATION DID NOT REACH THE INTENDED AREA. THE PROVIDER DOES READJUST THE SYRINGE/NEEDLE CONNECTION TO VERIFY FULL CONTACT IS IN TACT. (B)(6) 2025 PATIENT WAS A CERVICAL MEDIAN BRANCH BLOCK. (B)(6) 2025 PATIENT WAS A LUMBAR MEDIAN BRANCH BLOCK. 4. ANY PHYSICAL SAMPLE AVAILABLE FOR INVESTIGATION? IF YES, PLEASE PROVIDE THE ADDRESS OF THE FACILITY FOR US TO SHIP THE RETURN LABEL? NO PHYSICAL SAMPLE IS AVAILABLE AS USED/DIRTY NEEDLES ARE PLACED IN THE SHARPS BUCKET AFTER THE PROCEDURE. 5. HOW MANY PATIENTS WERE AFFECTED BY THE REPORTED LEAKS? 2. 6. ARE INDIVIDUAL EVENT DATES AVAILABLE FOR EACH OF THE REPORTED OCCURRENCES? IF YES, PLEASE PROVIDE THE DATES. (B)(6) 2025.
IT WAS REPORTED THAT BD UNKNOWN PRODUCT LEAKED. IT WAS REPORTED BY CUSTOMER THAT THEY HAVE TWO MORE INCIDENTS ON A LIST OF LEAKING. RCC RECEIVED A COMPLAINT VIA EMAIL. I DO HAVE 2 MORE INCIDENTS ON A LIST OF LEAKING DATES/LOT #. HOWEVER, I DIDN'T KNOW OF THE TIME LIMIT TO KEEP THE COMPLAINT OPEN. I WILL CONTACT YOU AGAIN IF THE PROVIDER AGREES TO REOPENING THE CASE.
NO ADDITIONAL INFORMATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2497607 | NEEDLE SPINAL S/SU 25GA 3-1/2IN QUINCKE | NEEDLE, CONDUCTION, ANESTHETIC (W/WO INTRODUCER) | BSP | BECTON DICKINSON | 4257390 | 00382904051808 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |