inforMED
MalfunctionCAF

ALBUTEROL SULFATE HFA INHALATION AEROSOL BY TEVA PHARMACEUTICALS

Received Jun 23, 2026 · Event occurred Jun 21, 2026

Report MW5189796 · MDR key 25594644

Device

Generic name

Nebulizer (direct Patient Interface)

Manufacturer

Unk

Product problems

  • No Device Output
  • Defective Device
  • Output below Specifications

Patient

60 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

THE REPORTER HAS 2 ASTHAM PUMPS, 1 STOPPED WORKING A WHILE AGO AND THE OTHER STOPPED WORKING LAST NIGHT. SHE TAKES A PUMP OF THE THIS MEDICATION AS PRECAUTION AND NOT AS A RESCUE MEDICATION TO ASTHMA ATTACK, HENCE THERE ARE NO ADVERSE EVENTS BECAUSE OF IT. HAD SHE BEEN IN AN ACTUAL. ASTHMA ATTACK, SHE THINKS THAT SHE WOULD HAVE DIED BECAUSE OF THE MALFUNCTION. 1 PUMP HAS 50 PUMPS LEFT AND THE OTHER WITH 38. SHE SHAKES THE DEVICE BEFORE ADMINISTRATION , ONLY MIST COMES OUT OF ONE DEVICE, PROBABLY 25% OF THE MEDICATION AND THE OTHER HAS NOTHING COMING OUT AFTER SPRAYING. SHE STATES THAT THE DEVICE HAS FAULTY MECHANISM. THESE DEVICES ARE GENERIC BRANDS SHE STATES. PT: 4582. DEVICE: 1435, 3004, 2588. REF: MW5189797. THIS REPORT CAPTURES ALBUTEROL SULFATE HFA INHALATION AEROSOL BY (B)(6).