CARDINAL HEALTH UNISTIK 3 NORMAL
Received Jun 10, 2026 · Event occurred May 11, 2026
Report 8021764-2026-00008 · MDR key 25460511
Device
Product problems
- Retraction Problem
- Misfire
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE BATCH FILE HAS BEEN REVIEWED WITH NO ANOMALIES NOTICED. LOT NUMBER 12743 ORIGINATED FROM LANCET BATCH 12234. THIS IS A SIMILAR COMPLAINT RECEIVED INVESTIGATED UNDER COMPLAINT (B)(4). RETENTION SAMPLES WERE TESTED AND ALL DEVICES WERE ABLE TO BE DISCHARGED AND NO DEVICE NON-RETRACTION SYMPTOMS OR OTHER ABNORMALITIES WERE IDENTIFIED. THE CONCLUSION WAS THAT THE REVIEW OF BATCH FILE RECORDS AND RETENTION SAMPLES DO NOT SHOW ANY ABNORMALITY THAT CAN CONTRIBUTE TO THE COMPLAINT DEFECT. IF THERE IS A SAMPLE RECEIVED, OMM WILL RE-OPEN THE COMPLAINT AND INVESTIGATE ON THE RETURNED SAMPLES. AS OF NOW, NO ACTION IS REQUIRED. OMM WILL CONTINUE TO MONITOR IF THERE ARE ANY SIMILAR COMPLAINTS IN THE FUTURE.
Description of Event or Problem
CARDINAL HEALTH REPORTED TO US THAT ONE OF THEIR CUSTOMERS REPORTED THERE HAVE BEEN 3 CASES OF NEEDLESTICK INJURY DURING USE OF THIS PRODUCT. BOTH ISSUES HAVE OCCURRED: 1. NOT FIRING (DISCHARGING) AFTER TOP IS TWISTED OFF. 2. AFTER FIRING (DISCHARGING) THE NEEDLES IS STILL EXPOSED (NOT RETRACTING). PT CODE: 4559 DEVICE CODES: 1536, 2532.