ARROW CANNON II PLUS REPLACEMENT HUB SET
Report
- Report Number
- 9680794-2024-00848
- Event Type
- Malfunction
- Date Received
- September 5, 2024
- Date of Event
- August 10, 2024
- Report Date
- August 12, 2024
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- NFK
- PMA / PMN Number
- K020430
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). THE CUSTOMER RETURNED ONE THREADED COMPRESSION CAP, CONNECTOR ASSEMBLY, AND COMPRESSION SLEEVE FOR EVALUATION. SIGNS OF USE WERE OBSERVED ON THE COMPRESSION CAP. VISUAL INSPECTION OF THE SAMPLE CONFIRMED A CRACK ALONG THE MOLDING SEAM OF THE COMPRESSION CAP. VISUAL AND MICROSCOPIC EXAMINATION REVEALED THAT THE GREEN COMPRESSION SLEEVE CONTAINED DAMAGE FROM BECOMING PINCHED BETWEEN THE THREADS OF THE COMPRESSION CAP AND CONNECTOR ASSEMBLY. EVALUATION OF THE CONNECTOR ASSEMBLY REVEALED THAT IT DOES NOT MATCH THE CUSTOMER REPORTED MATERIAL. ANALYSIS OF THE DEFECTIVE COMPONENT, THE COMPRESSION FITTING, REVEALED THAT IT IS A STANDARD COMPONENT BETWEEN CHRONIC HEMODIALYSIS KITS AND REPLACEMENT SETS. THEREFORE, DESPITE THE CONNECTOR ASSEMBLY DISCREPANCY, SINCE THE CUSTOMER REPORT WAS CONFIRMED, THE DEFECT WAS INVESTIGATED. R & D WAS PREVIOUSLY CONTACTED AS A PART OF THIS COMPLAINT INVESTIGATION. THEY CONFIRMED THAT OVER-TIGHTENING OF THE COMPRESSION CAP DURING USE LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THE KIT INFORMS THE USER, "GREEN COMPRESSION SLEEVE MUST BE PRESENT WHEN THREADING COMPRESSION CAP ONTO HUB CONNECTION ASSEMBLY. FAILURE TO DO SO MAY RESULT IN AIR EMBOLISM, BLOOD LOSS, OR CATHETER SEPARATION". THE IFU ALSO STATES, "THREAD COMPRESSION CAP ONTO HUB CONNECTION ASSEMBLY FIRMLY, BUT DO NOT OVER TIGHTEN. THERE SHOULD BE NO THREADS VISIBLE ON HUB CONNECTION ASSEMBLY." THE REPORT OF A DAMAGED COMPRESSION CAP WAS CONFIRMED THROUGH COMPLAINT INVESTIGATION OF THE RETURNED SAMPLE. VISUAL AND MICROSCOPIC ANALYSIS REVEALED A CRACK IN THE COMPRESSION CAP. THREAD IMPRINTS WERE OBSERVED ON THE GREEN COMPRESSION SLEEVE, WHICH LIKELY OCCURRED FROM BEING PINCHED BETWEEN THE CONNECTOR ASSEMBLY AND COMPRESSION CAP. BASED ON THE SAMPLE RECEIVED, THE REPORT FROM THE CUSTOMER, AND THE PRIOR COMMENTS FROM R & D, UNINTENTIONAL USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THIS EVENT. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS IF THIS NATURE.
(B)(4). UDI NOT COMPLETE AS THE LOT# WAS NOT PROVIDED BY CUSTOMER.
IT WAS REPORTED THAT: "THE WHITE THREADED COMPRESSION CAP HAD A TEAR ALONG THE ENTIRE LENGTH OF THE CAP FOR NO APPARENT REASON. AS A RESULT, BLOOD WAS ALSO LEAKING OUT AND THE ATTACHMENT WAS HEAVILY ENCRUSTED. THE CATHETER WAS IN SITU FOR 12 MONTHS WITHOUT ANY PROBLEMS. THE DAMAGED HUB WAS REMOVED AND REPLACED WITH A REPLACEMENT HUB. CATHETER SHOWED NO LEAKS AND COULD BE USED FOR DIALYSIS. SO FAR UNEVENTFUL IN USE. THE EVENT HAD NO INFLUENCE ON THE PATIENT'S HEALTH SITUATION. THE PATIENT IS REPORTED AS BEING GOOD AND STABLE.".
IT WAS REPORTED THAT: "THE WHITE THREADED COMPRESSION CAP HAD A TEAR ALONG THE ENTIRE LENGTH OF THE CAP FOR NO APPARENT REASON. AS A RESULT, BLOOD WAS ALSO LEAKING OUT AND THE ATTACHMENT WAS HEAVILY ENCRUSTED. THE CATHETER WAS IN SITU FOR 12 MONTHS WITHOUT ANY PROBLEMS. THE DAMAGED HUB WAS REMOVED AND REPLACED WITH A REPLACEMENT HUB. CATHETER SHOWED NO LEAKS AND COULD BE USED FOR DIALYSIS. SO FAR UNEVENTFUL IN USE. THE EVENT HAD NO INFLUENCE ON THE PATIENT'S HEALTH SITUATION. THE PATIENT IS REPORTED AS BEING GOOD AND STABLE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1386124 | ARROW CANNON II PLUS REPLACEMENT HUB SET | KIT, REPAIR, CATHETER, HEMODI | NFK | ARROW INTERNATIONAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED.| NOT REPORTED. |