SAMMC ANGIOGRAPHY TRAY
Received Feb 20, 2026 · Event occurred Jan 26, 2026
Report MW5184157 · MDR key 24402756
Device
Generic name
Cardiac Catheterization Kit
Catalog number
SAMM066-15
Lot number
1663931
Product problems
- Unraveled Material
- Unintended Movement
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
TECHNICIANS HAVE REPORTED THAT THE SYRINGE (PHOTO 1) IS UNRAVELING FROM THE ATTACHED MANIFOLD PORT (PHOTO 2). THE SYRINGE IS ALSO VERY WOBBLY WHEN ATTACHED TO THE MANIFOLD. THIS HAS BEEN SEEN 3 TIMES IN THE LAST WEEK. THEY ALSO INFORMED THAT THIS IS A REOCCURRING ISSUE WITH THE SYRINGE UNRAVELING. THE MAIN PACK IS PART NO: SAMM06615.THE MANIFOLD/SYRINGE PACK THAT COMES IN THE MAIN PACK IS REF 650204216: NAMIC CONVENIENCE KIT. LOT# 0000177238 (PHOTO 3). 1.00 KIT CUSTOM // 650204216 END RESULT: SWITCH OUT SYRINGES OR ADD A SYRINGE THAT IS NOT FROM THE LOT NUMBER. PT CODE: 4582. DEVICE CODES: 3026, 1664. REF REPORT: MW5184156.