ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM
Report
- Report Number
- 9680794-2026-00138
- Event Type
- Injury
- Date Received
- February 25, 2026
- Date of Event
- January 29, 2026
- Report Date
- January 29, 2026
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- FOZ
- PMA / PMN Number
- K071538
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
(B)(4). COMPLAINT VERIFICATION TESTING COULD NOT BE PERFORMED AS IT WAS REPORTED THAT THE SAMPLE IS NOT AVAILABLE FOR RETURN. THE CUSTOMER REPORTED, "IN THESE CASES, THE PRIMARY SECUREMENT METHOD USED WAS THE SECONDSITE ADJUSTABLE FASTENER WITH SUTURES INCLUDED IN THE KIT, AND THE CATHETER HUB ITSELF WAS NOT SUTURED. PER THE IFU, BOTH THE CATHETER HUB AND THE SECONDSITE ADJUSTABLE FASTENER SHOULD BE SECURED." THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT WARNS THE USER, "A CATHETER CLAMP AND FASTENER ARE USED TO SECURE CATHETER WHEN AN ADDITIONAL SECUREMENT SITE OTHER THAN THE CATHETER HUB IS REQUIRED FOR CATHETER STABILIZATION. USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY." ADDITIONALLY, TEN YEARS OF COMPLAINT HISTORY FOR CATHETER LC-15703-022, CLAMP CATHETER K-14703-013A, AND CLAMP FASTENER K-14703-007A WERE REVIEWED AND THERE WERE NO CONFIRMED QUALITY CONCERNS RELATED TO THE FIT OR PLACEMENT OF THE SECONDSITE ADJUSTABLE FASTENER WITH THE ASSOCIATED CVC. THE IFU P ROVIDED WITH THIS KIT WARNS THE USER, "A CATHETER CLAMP AND FASTENER ARE USED TO SECURE CATHETER WHEN AN ADDITIONAL SECUREMENT SITE OTHER THAN THE CATHETER HUB IS REQUIRED FOR CATHETER STABILIZATION. USE CATHETER HUB AS PRIMARY SECUREMENT SITE. USE CATHETER CLAMP AND FASTENER AS A SECONDARY SECUREMENT SITE AS NECESSARY." BASED ON THE CUSTOMER REPORT, IT WAS DETERMINED THAT USE ERROR LIKELY CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. A CUSTOMER IN-SERVICE WAS INITIATED TO INSTRUCT THE CUSTOMER ON PROPER USE OF THE DEVICE. TELEFLEX WILL CONTINUE TO MONITOR AND TREND ON COMPLAINTS OF THIS NATURE.
(B)(4).
IT WAS REPORTED THAT "I WAS INFORMED THAT (B)(6) HOSPITAL EXPERIENCED THREE OCCURRENCES IN WHICH CVCS PULLED BACK FROM THEIR ORIGINAL PLACEMENT. IN THESE CASES, THE PRIMARY SECUREMENT METHOD USED WAS THE SECONDSITE ADJUSTABLE FASTENER WITH SUTURES INCLUDED I THE KIT, AND THE CATHETER HUB ITSELF WAS NOT SUTURED. PER THE IFU, BOTH THE CATHETER HUB AND THE SECONDSITE ADJUSTABLE FASTENER SHOULD BE SECURED. ONE OF THESE EVENTS REPORTEDLY RESULTED IN A CODE SITUATION FOR THE PATIENT. BASED ON THE INFORMATION SHARED, THIS MAY BE RELATED TO USER EDUCATION REGARDING THE REQUIREMENT TO SECURE BOTH SITES." THE PATIENT'S CURRENT CONDITION IS UNKNOWN. ASSOCIATE MDR NUMBERS INCLUDE: 9680794-2026-00143, 9680794-2026-00138, AND 9680794-2026-00137.
IT WAS REPORTED THAT "I WAS INFORMED THAT ST. CLOUD HOSPITAL EXPERIENCED THREE OCCURRENCES IN WHICH CVCS PULLED BACK FROM THEIR ORIGINAL PLACEMENT. IN THESE CASES, THE PRIMARY SECUREMENT METHOD USED WAS THE SECOND SITE ADJUSTABLE FASTENER WITH SUTURES INCLUDED I THE KIT, AND THE CATHETER HUB ITSELF WAS NOT SUTURED. PER THE IFU, BOTH THE CATHETER HUB AND THE SECONDSITE ADJUSTABLE FASTENER SHOULD BE SECURED. ONE OF THESE EVENTS REPORTEDLY RESULTED IN A CODE SITUATION FOR THE PATIENT. BASED ON THE INFORMATION SHARED, THIS MAY BE RELATED TO USER EDUCATION REGARDING THE REQUIREMENT TO SECURE BOTH SITES." THE PATIENT'S CURRENT CONDITION IS UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 503523 | ARROW MULTILUMEN PI CVC KIT: 3L 7 FR X 20 CM | CATHETER INTRAVASCULAR THERAP | FOZ | ARROW INTERNATIONAL LLC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |