MEDLINE
Received Jul 8, 2026 · Event occurred Jun 9, 2026
Report 1423395-2026-00366 · MDR key 25752581
Device
Generic name
Ro-diep Pack
Manufacturer
Medline Industries, LpCatalog number
DYNJ82393C
Lot number
25KBA529
Product problems
- Appropriate Device Problem Term/Code Not Available
Patient
Not reported
- Hemorrhage/Blood Loss/Bleeding
Narrative
Additional Manufacturer Narrative
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE SURGEON REQUESTED ANOTHER CLIP APPLIER THAT WAS FROM THEIR DIEP PACK AND WAS FROM THE SAME LOT NUMBER AS THE FIRST AND WHEN IT WAS USED TO CLIP TO THE VESSEL IT ALSO CUT THE VESSEL. THE SURGEON USED THE PRODUCT TO ATTACH A CLIP TO THE VESSEL IN THE USUAL FASHION AND THE PRODUCT CUT THE VESSEL. PER THE SURGEON THE BULLDOG CLAMP WAS APPLIED TO THE VESSEL TO CONTROL THE BLEEDING WHILE THE CIRCULATING RN WENT TO RETRIEVE A THIRD MEDIUM CLIP APPLIER FROM THE SUPPLY ROOM. THE CLIP WAS SUCCESSFULLY APPLIED. PER THE SURGEON THE PATIENT IS DOING WELL. IT HAS BEEN DETERMINED THAT THE REPORTED EVENT CAUSED OR CONTRIBUTED TO A DEATH OR SERIOUS INJURY. BASED ON THE INFORMATION REVIEWED, THIS IS A REPORTABLE EVENT AS DEFINED UNDER 21 CFR 803.3.
Description of Event or Problem
ACCORDING TO THE FACILITY ON (B)(6) 2026, THE SURGEON REQUESTED ANOTHER CLIP APPLIER THAT WAS FROM THEIR DIEP PACK AND WAS FROM THE SAME LOT NUMBER AS THE FIRST AND WHEN IT WAS USED TO CLIP TO THE VESSEL IT ALSO CUT THE VESSEL. THE SURGEON USED THE PRODUCT TO ATTACH A CLIP TO THE VESSEL IN THE USUAL FASHION AND THE PRODUCT CUT THE VESSEL.