ARROW PSI SET: 9 FR
Report
- Report Number
- 9680794-2025-00679
- Event Type
- Malfunction
- Date Received
- August 11, 2025
- Date of Event
- June 23, 2025
- Report Date
- July 17, 2025
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DYB
- PMA / PMN Number
- K780532
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4).
(B)(4). THE CUSTOMER PROVIDED ONE IMAGE SHOWING AN OBTURATOR FOR ANALYSIS. IT IS ASSUMED THAT THIS PICTURE WAS PROVIDED FOR REFERENCE ONLY. THE CUSTOMER ALSO RETURNED ONE PSI FOR ANALYSIS. SIGNS OF USE WERE OBSERVED ON THE SAMPLE. THE OBTURATOR WAS IN PLACE AND CORRECTLY LOCKED OVER THE HEMOSTASIS BODY/CAP. IT WAS ALSO NOTED THAT THE SIDE ARM WAS DISCONNECTED FROM THE HEMOSTASIS BODY. VISUAL ANALYSIS REVEALED THAT THE OBTURATOR WAS CORRECTLY LOCKED OVER THE HEMOSTASIS BODY/CAP. THE OBTURATOR WAS UNLOCKED AND REMOVED. LARGE QUANTITIES OF DRIED BIOLOGICAL MATERIAL WERE LOCATED AROUND THE HEMOSTASIS BODY AND INSIDE OBTURATOR. THE BIOLOGICAL MATERIAL WAS CLEANED OFF THE SAMPLE. ONCE REMOVED, THE OBTURATOR WAS ABLE TO BE REINSERTED AND REMOVED AS INTENDED. THE INNER DIAMETER OF THE HEMOSTASIS CAP MEASURED 0.127", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.124"-0.127". THE OUTER DIAMETER OF THE PRONG WITHIN THE OBTURATOR MEASURED 0.106", WHICH IS WITHIN THE SPECIFICATION LIMITS OF 0.103"-0.107" PER THE OBTURATOR PRODUCT DRAWING. THE OBTURATOR WAS REMOVED FROM THE HEMOSTASIS BODY/CAP WITH LITTLE TO NO RESISTANCE. THE BIOLOGICAL MATERIAL WAS REMOVED, AND THE OBTURATOR WAS ABLE TO BE INSERTED/LOCKED AND REMOVED/UNLOCKED WITH NO ISSUE. PERFORMED PER IFU STATEMENT, "TEMPORARILY COVER VALVE OPENING WITH STERILE-GLOVED FINGER UNTIL OBTURATOR IS INSERTED. APPLY OBTURATOR CAP". FURTHER FUNCTIONAL LEAK TESTING COULD NOT BE PERFORMED ON THE PSI DUE TO THE SEPARATION OF THE SIDEARM. THE IFU PROVIDED WITH THE KIT INFORMS THE USER, "HEMOSTASIS VALVE MUST BE OCCLUDED AT ALL TIMES TO REDUCE THE RISK OF AIR EMBOLISM , CONTAMINATION OR HEMORRHAGE. IN THE ABSENCE OF AN INDWELLING CENTRAL CATHETER USE THE ARROW OBTURATOR TO OCCLUDE HEMOSTASIS VALVE". THE REPORT OF AN UNSECURE OBTURATOR CONNECTION WAS NOT ABLE TO BE CONFIRMED THROUGH COMPLAINT INVESTIGATION. THE OBTURATOR AND HEMOSTASIS BODY MET ALL RELEVANT VISUAL, DIMENSIONAL, AND FUNCTIONAL REQUIREMENTS; HOWEVER, BECAUSE FUNCTIONAL LEAK TESTING CANNOT BE PERFORMED ON THE RETURNED PSI, THE ROOT CAUSE CANNOT BE DETERMINED AT THIS TIME. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED "THE INTRODUCER WAS IN PLACE BUT NO LONGER IN USE (SWAN-GANZ). THE NURSE TRIED TO PLUG THE INTRODUCER USING THE STOPPER SUPPLIED IN THE KIT, BUT THE STOPPER WOULDN'T STAY IN PLACE. HE WAS ABLE TO PUSH IT IN BUT NOT HOLD IT IN PLACE. THEY REMOVED THE INTRODUCER, WHICH WAS NO LONGER USEFUL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
IT WAS REPORTED "THE INTRODUCER WAS IN PLACE BUT NO LONGER IN USE (SWAN-GANZ). THE NURSE TRIED TO PLUG THE INTRODUCER USING THE STOPPER SUPPLIED IN THE KIT, BUT THE STOPPER WOULDN'T STAY IN PLACE. HE WAS ABLE TO PUSH IT IN BUT NOT HOLD IT IN PLACE. THEY REMOVED THE INTRODUCER, WHICH WAS NO LONGER USEFUL." THE PATIENT'S CURRENT CONDITION IS REPORTED AS "FINE".
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2002655 | ARROW PSI SET: 9 FR | INTRODUCER, CATHETER | DYB | ARROW INTERNATIONAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |