MINIBAG PLUS CONTAINER
Received Apr 11, 2026 · Event occurred Dec 1, 2025
Report 1416980-2026-01270 · MDR key 24848145
Device
Generic name
See H11
Manufacturer
Baxter Healthcare CorporationModel number
2C4950Catalog number
2C4950
Lot number
NA
Product problems
- Failure to Align
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A MINI-BAG PLUS DOCKING ASSIST TOOL WAS BROKEN. THIS ISSUE WAS IDENTIFIED DURING AND AFTER USE. AFTER REPEATED USE, THE SCREWS AND ALIGNMENT BECAME OFF (TWO ARMS ON TOP WERE NOT ALIGNED). THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
D2A: COMMON DEVICE NAME: EQUIPMENT, LABORATORY, GENERAL PURPOSE, LABELED OR PROMOTED FOR A SPECIFIC MEDICAL USE SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION: H6 (UPDATE CODES), H11. H11: THE DEVICE WAS NOT RETURNED AND THE LOT NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.