NEEDLE SPINAL S/SU 18GA 6IN QUINCKE
Received Feb 12, 2026 · Event occurred Jan 24, 2026
Report 2618282-2026-00029 · MDR key 24322466
Device
Generic name
Needle, Conduction, Anesthetic (w/wo Introducer)
Manufacturer
Bd Caribe Ltd.Catalog number
408360
Lot number
3041717
Product problems
- Contamination
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
NO ADDITIONAL INFORMATION.
Additional Manufacturer Narrative
INVESTIGATION RESULTS: THREE PHOTOS AND FOUR PHYSICAL SAMPLES WERE RECEIVED BY OUR QUALITY TEAM FOR EVALUATION. THE IMAGES INCLUDE THE TYVEK PACKAGING WITH CATALOG NUMBER, BATCH NUMBER, AND EXPIRATION DATE, AS WELL AS A TIP OF A NEEDLE; ACCORDING TO THE VOICE OF THE CUSTOMER, THE MATERIAL PASSED THROUGH THE NEEDLE AND WITHDREW IN A DIRTY CONDITION (FOREIGN MATTER). THE SAMPLES RECEIVED WERE SEALED AND UNUSED IN THEIR PACKAGING BLISTER. THEY WERE SUBMITTED TO INSPECTION FOR TESTING. THE INSPECTION WAS EXECUTED, AND THE SAMPLES COMPLY WITH THE EXPECTED CHARACTERISTICS, THE REPORTED FAILURE WAS NOT OBSERVED IN THE NEEDLES. A DEVICE HISTORY RECORD REVIEW FOUND NO NON-CONFORMANCES ASSOCIATED WITH THIS ISSUE DURING PRODUCTION OF THIS BATCH. BASED ON THE QUALITY TEAM'S INVESTIGATION, A ROOT CAUSE COULD NOT BE DETERMINED. THIS INCIDENT HAS BEEN ADDED TO OUR DATABASE OF REPORTED INCIDENTS.
Additional Manufacturer Narrative
H.3. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem
A BLACK SUBSTANCE WAS OBSERVED ON PRODUCT THAT PASSED THROUGH THE SPINAL NEEDLE. NO PATIENT HARM.