NEEDLE SPINAL S/SU 26GA 3-1/2IN QUINCKE

Description of Event or Problem

TODAY DEXCO NOTIFIES THAT IN THE (B)(6) CLINIC THERE IS A DISSATISFACTION ON THE PART OF THE GROUP OF ANESTHESIOLOGISTS OF THE INSTITUTION REGARDING THE USE OF THE BD SPINAL PROBE, FOR WHICH THEY ARE RETURNING THE ORDER AWARDED BY BIONEXO. THE MAIN CAUSE FOR CONCERN IS THE LEAKAGE OF MEDICATION BETWEEN THE THREAD OF THE SPINAL PROBE AND THE SYRINGE (PRECISION CARE) USED TO ADMINISTER THE MEDICATION DURING THE PROCEDURES, AND THEY ALSO REPORT THAT THESE NEEDLES, WHICH WERE DELIVERED BY ANOTHER DISTRIBUTOR, ARRIVED WITH A DEFORMITY IN THEIR PRIMARY PACKAGING (CURVATURE).

Additional Manufacturer Narrative

INITIAL MDR SUBMISSION. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED. H3 OTHER TEXT: SEE H10 MANUFACTURE NARRATIVE.

Description of Event or Problem

ADDITIONAL INFORMATION: HAS THERE BEEN ANY HARM TO PATIENTS/HEALTHCARE PROFESSIONALS? A: NO WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION DUE TO THE INCIDENCE (IMAGING TESTS, SURGERY, DRUG ADMINISTRATION, ETC.)? (DETAIL) A: NO WAS THERE EXPOSURE OF BLOOD/CHEMOTHERAPY TO MUCOUS MEMBRANES (EYES, NOSE AND MOUTH) OR SKIN? IF YES, INDICATE WHETHER THE EXPOSURE WAS FROM THE PATIENT OR THE PRACTITIONER AND WHAT MEASURES WERE TAKEN. (DETAIL) A: NO FOR SAMPLE COLLECTION: PLEASE INFORM: HOW MANY UNITS ARE AVAILABLE FOR COLLECTION? NO SAMPLES.

Additional Manufacturer Narrative

PHOTOS RECEIVED FOR INVESTIGATION. THROUGH VISUAL INSPECTION, IT IS OBSERVED IN THE PHOTOS THE TYVEK WITH THE PRODUCT¿S INFORMATION (GAGE, INCHES, LOT AND BATCH NUMBER AND EXPIRATION DATE) AND A SMALLER LABEL PLACED ON THE TOP OF THE NEEDLE¿S BLISTER. THE NEEDLE IS UNUSED AND UNOPENED; SEALED IN ITS BLISTER. NO ACTUAL SAMPLES WERE RECEIVED. NO DEFECT OR ISSUES OBSERVED. PHYSICAL SAMPLES ARE REQUIRED TO FURTHER ANALYZE. 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. BASED ON THE QUALITY TEAM'S INVESTIGATION, WE ARE NOT ABLE TO IDENTIFY A ROOT CAUSE RELATED TO OUR MANUFACTURING PROCESS AT THIS TIME.