BD SPINAL/EPIDURAL NEEDLES & TRAYS

Additional Manufacturer Narrative

E. STREET ADDRESS EXCEEDS CHARACTER LIMIT: (B)(6). H.3. A FOLLOW UP MDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION, A DEVICE EVALUATION, OR A DEVICE HISTORY REVIEW IS COMPLETED.

Description of Event or Problem

IT WAS REPORTED THAT BD SPINAL/EPIDURAL NEEDLES & TRAYS NEEDLE BROKE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM PORTUGUESE TO ENGLISH: DESCRIPTION OF THE OCCURRENCE (DESCRIBE THE DEVIATION OBSERVED, THE DETAILS AND THE OUTCOME OF THE CASE): DURING SPINAL ANESTHESIA, WHEN REMOVING THE PROBE AFTER INJECTING THE ANESTHETIC, PATIENT MOVED ABRUPTLY AND UNEXPECTEDLY, CAUSING A FRACTURE OF THE NEEDLE, WHICH GOT STUCK IN THE MUSCLE FASCIA AND SUBCUTANEOUS TISSUE. THE PATIENT'S BACK HAD TO BE OPENED BY A SPINAL SPECIALIST TO REMOVE THE NEEDLE UNDER DIRECT VISUALIZATION AND GUIDED BY SCOPY. DATE OF IDENTIFICATION OF OCCURRENCE; ON (B)(6) 2024 QUANTITY IDENTIFIED WITH DEVIATION. AT WHAT POINT WAS THE OCCURRENCE WITH THE PRODUCT IDENTIFIED (BEFORE STARTING THE PROCEDURE, DURING HANDLING OF THE PRODUCT BY THE PROFESSIONAL/USER, DURING USE ON THE PATIENT OR AFTER USE ON THE PATIENT)? DURING USE ON THE PATIENT WAS THERE ANY HARM TO THE PATIENT, HEALTHCARE PROFESSIONAL, USER OR OTHER? (GIVE DETAILS); THERE WAS HARM TO THE PATIENT, AS SHE HAD TO UNDERGO SURGERY TO REMOVE THE PROBE WHICH HAD BECOME TRAPPED IN THE SUBCUTANEOUS TISSUES AND MUSCULAR FASCIA. WAS THERE A NEED FOR MEDICAL AND/OR SURGICAL INTERVENTION BECAUSE OF WHAT HAPPENED (IMAGING TESTS, SURGERY, MEDICATION ADMINISTRATION, ETC.)? (PLEASE PROVIDE DETAILS); THERE WAS A NEED FOR SURGERY, IMAGING TESTS (MRI) AND FOLLOW-UP OF THE CASE. TELL US IF THE SAMPLE THAT SHOWED THE DEVIATION IS AVAILABLE FOR ANALYSIS; YES, IT IS AVAILABLE. IF POSSIBLE, ATTACH PHOTO SAMPLES OF THE MATERIAL WITH THE DEVIATION AND ITS PACKAGING, WHERE THE OCCURRENCE REPORTED CAN BE CLEARLY SEEN. WAS THERE ANY DAMAGE TO THE NEEDLE BEFORE/DURING USE? NO THE CATALOG NUMBER CANNOT BE FOUND. PLEASE CONFIRM THE CATALOG NUMBER AND BATCH NUMBER OF THE PRODUCT. PLEASE SEND PHOTO SAMPLES OF THE PACKAGING/LABEL, IF AVAILABLE. IF NOT AVAILABLE, ARE THERE ANY UNUSED PRODUCTS IN THE OFFICE TO LOCATE THE CATALOG AND BATCH NUMBER? HOW MANY PRODUCTS WERE AFFECTED? ONLY ONE COULD THE PROCEDURE BE COMPLETED? YES WHAT WAS THE OUTCOME FOR PATIENT? PATIENT REQUIRED SURGERY TO REMOVE THE NEEDLE FRAGMENT.

Description of Event or Problem

NO ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

TO AID IN THE INVESTIGATION OF THIS ISSUE, THREE (3) PICTURE SAMPLES WERE RECEIVED FOR EVALUATION BY OUR QUALITY TEAM. TWO (2) OF THE PICTURES DISPLAYED THE PRODUCTS UNIT PACKAGING, WHICH CONTAINED THE PRODUCT CODE AND CALIBER INFORMATION. ONE (1) OF THE PICTURES DISPLAYED THE NEEDLE PRODUCT AND IT WAS OBSERVED THAT THE NEEDLE WAS BROKEN IN HALF. ALTHOUGH THE PROVIDED PICTURE SAMPLE SHOWS THE REPORTED ISSUE, AS THE LOT NUMBER WAS UNKNOWN FOR THIS INCIDENT, IT WAS NOT POSSIBLE TO COMPLETE A DETAILED INVESTIGATION FOR THE PRODUCT IN QUESTION. A REVIEW OF THE APPLICABLE PRODUCTION HISTORY RECORDS COULD NOT BE COMPLETED. ACCORDING TO THE DESCRIPTION OF THE COMPLAINT, ¿DURING THE PERFORMANCE OF A SPINAL ANESTHESIA, WHEN REMOVING THE NEEDLE, AFTER THE INJECTION OF THE ANESTHETIC, THE PATIENT MOVED ABRUPTLY AND UNEXPECTEDLY, CAUSING THE NEEDLE TO FRACTURE, WHICH BECAME STUCK IN THE MUSCLE FASCIA AND SUBCUTANEOUS TISSUE¿, A PROBABLE CAUSE MAY BE RELATED TO THE SUDDEN MOVEMENT THAT THE PATIENT MADE UNEXPECTEDLY, RESULTING IN THE REPORTED DEFECT AS DESCRIBED. AT THIS TIME, FURTHER ACTION HAS NOT BEEN DETERMINED NECESSARY. OUR QUALITY TEAM WILL CONTINUE TO CLOSELY MONITOR THE MANUFACTURING PROCESS FOR SIGNS OF THIS POTENTIAL DEFECT AND ANY EMERGING TRENDS.