inforMED
MalfunctionDTL

PHD¿

Received Aug 5, 2025 · Event occurred Jun 13, 2025

Report 22714029 · MDR key 22714029

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Product code (DTL)
Manufacturer (Merit Medical Systems, Inc.)
Model (T)

Device

Generic name

Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass

Model number

T

Catalog number

MAP802

Lot number

I3200996

Product problems

  • Output Problem

Patient

NA · Unknown

  • Insufficient Information
  • Insufficient Information

Narrative

Description of Event or Problem

TECHS TESTED A FEW MAP802 LOT I3200996, SPRING WILL NOT BOUNCE BACK. CLINICAL SITE NOTIFIED MFG REP [MANUFACTURER REPRESENTATIVE] DIRECTLY OF EVENT AND COORDINATING RETURN OF PRODUCT. MANUFACTURER RESPONSE FOR ANGIOPLASTY PACK, (BRAND NOT PROVIDED) (PER SITE REPORTER).