MalfunctionGBA

RUSCH

Received Feb 27, 2026 · Event occurred Feb 13, 2026

Report 24469092 · MDR key 24469092

Device

Generic name

Catheter, Balloon Type

Manufacturer

Teleflex Incorporated

Model number

IPN052734

Catalog number

564000

Lot number

40A25H2767

Patient

26 YR · Unknown

No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

WORD BARTHOLIN GLAND CATHETERS - MULTIPLE PROVIDERS REPORTING THEY ARE UNABLE TO INFLATE THE BALLOON BECAUSE OF A HOLE PRESENT IN THE CATHETER THAT SHOULD NOT BE THERE.. LOT NUMBER 40A25H2767. REF # 564000 MANUFACTURING DATE 8/16/25, EXPIRATION DATE 07/31/2030. NO REPORTED PATIENT HARM.