RHV
Received Jan 12, 2026 · Event occurred Dec 17, 2025
Report 2024168-2026-00213 · MDR key 24039004
Device
Generic name
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
Manufacturer
Abbott Vascular Inc.Model number
23242Catalog number
23242
Lot number
60638870
Product problems
- Loose or Intermittent Connection
- Unstable
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS UNKNOWN WHAT MAY HAVE CAUSED THE REPORTED LOOSE OR INTERMITTENT CONNECTION AND UNSTABLE. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
Description of Event or Problem
IT WAS REPORTED THE THREE-WAY STOPCOCK DID NOT FIT SECURELY INTO THE ROTATING HEMOSTATIC VALVE (RHV), AND THE CONNECTION PART REMAINED LOOSE, ROTATING FREELY. ATTEMPTS TO RECONNECT WERE UNSUCCESSFUL; THEREFORE, A NEW Y-CONNECTOR WAS USED. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.
Additional Manufacturer Narrative
B5 - PROCEDURE DESCRIPTION WAS UPDATED. H6 - MEDICAL DEVICE PROBLEM CODE 1667 WAS REMOVED. THE DEVICE WAS NOT RETURNED FOR ANALYSIS. PRODUCTION RECORD AND CORRECTIVE AND PREVENTATIVE ACTIONS (CAPA) REVIEWS WERE PERFORMED AND REVEALED NO INDICATION OF A PRODUCT QUALITY ISSUE. ADDITIONALLY, A QUERY OF THE COMPLAINT HANDLING DATABASE FOR THE REPORTED LOT REVEALED THERE IS NO INDICATION OF A LOT SPECIFIC ISSUE. BASED ON THE INFORMATION PROVIDED AND BECAUSE THE DEVICE WAS NOT RETURNED FOR ANALYSIS, IT IS UNKNOWN WHAT MAY HAVE CAUSED THE REPORTED LOOSE OR INTERMITTENT CONNECTION. THE INVESTIGATION DETERMINED A CONCLUSIVE CAUSE FOR THE REPORTED DIFFICULTIES CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE.
Description of Event or Problem
SUBSEQUENTLY AFTER THE INITIAL REPORT HAD ALREADY BEEN FILED, IT WAS NOTED THAT THE ROTATOR OF THE THREE-WAY STOPCOCK WAS ROTATING FREELY. NO ADDITIONAL INFORMATION WAS PROVIDED.