ARROW CVC KIT: 4-LUMEN 8.5FR X 16 CM
Report
- Report Number
- 3006425876-2024-00920
- Event Type
- Malfunction
- Date Received
- September 27, 2024
- Date of Event
- September 3, 2024
- Report Date
- September 3, 2024
- Manufacturer
- ARROW INTERNATIONAL LLC
- Product Code
- DQY
- PMA / PMN Number
- K071538
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
QN# (B)(4). FULL UDI IS NOT AVAILABALE AS THE LOT# WAS NOT PROVIDED BY THE CUSTOMER.
QN# (B)(4). THE ACTUAL DEVICE WAS NOT RETURNED; HOWEVER, THE CUSTOMER PROVIDED ONE PHOTO FOR EVALUATION. THE COMPLAINT OF A SEPARATED LUER HUB WAS ABLE TO BE CONFIRMED BY THE PHOTO AS IT REVEALED THE SEPARATION OF THE MEDIAL LUER HUB. HOWEVER, A COMPLETE VISUAL INSPECTION TO DETERMINE THE NATURE AND CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. THE CUSTOMER DID NOT PROVIDE A LOT NUMBER; THEREFORE, A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED UPON A LOT NUMBER TAKEN FROM THE SALES HISTORY DATA OF THE CUSTOMER. NO RELEVANT FINDINGS WERE IDENTIFIED. THE INSTRUCTIONS FOR USE (IFU) PROVIDED WITH THIS KIT INFORMS THE USER, "DO NOT APPLY EXCESSIVE FORCE IN PLACING OR REMOVING CATHETER OR GUIDEWIRE. EXCESSIVE FORCE CAN CAUSE COMPONENT DAMAGE OR BREAKAGE. IF DAMAGE IS SUSPECTED OR WITHDRAWAL CANNOT BE EASILY ACCOMPLISHED, RADIOGRAPHIC VISUALIZATION SHOULD BE OBTAINED AND FURTHER CONSULTATION REQUESTED." THE IFU ALSO STATES, "WARNING: OPEN SLIDE CLAMP PRIOR TO INFUSION THROUGH LUMEN TO REDUCE RISK OF DAMAGE TO EXTENSION LINE FROM EXCESSIVE PRESSURE." THE CUSTOMER REPORT OF SEPARATED LUER HUB WAS CONFIRMED BY VISUAL INSPECTION OF THE CUSTOMER SUPPLIED PHOTO. THE IMAGE SHOWS A MEDIAL LUER HUB SEPARATED FROM THE EXTENSION LINE, HOWEVER, FULL COMPLAINT VERIFICATION TESTING TO EVALUATE THE CAUSE OF THE DAMAGE COULD NOT BE PERFORMED AS NO SAMPLE WAS RETURNED FOR ANALYSIS. A DEVICE HISTORY RECORD REVIEW WAS PERFORMED BASED ON A POTENTIAL LOT FROM SALES HISTORY, AND NO RELEVANT FINDINGS WERE IDENTIFIED. WITHOUT THE DEVICE TO EVALUATE, THE PROBABLE CAUSE COULD NOT BE DETERMINED FROM THE AVAILABLE INFORMATION. TELEFLEX WILL CONTINUE TO MONITOR AND TREND FOR REPORTS OF THIS NATURE.
IT WAS REPORTED THAT: "I JUST INSERTED A CVC INTO A PATIENT WITH K 2.6 AND QTC 600 AFTER INSERTION (WHICH WAS PRETTY UNREMARKABLE) BLUE CAP FELL OFF. IT WAS NOTED BY THE NURSING STAFF, WHO REPORT THEY NOTED IT WHILST PREPARING FOR A ROLL, AND NOT AFTER NURSING INTERVENTION / INADVERTENT PULLING ETC. NO AIR EMBOLI OR OTHER ACUTE COMPLICATION IS APPARENT."
IT WAS REPORTED THAT: "I JUST INSERTED A CVC INTO A PATIENT WITH K 2.6 AND QTC 600 AFTER INSERTION (WHICH WAS PRETTY UNREMARKABLE) BLUE CAP FELL OFF. IT WAS NOTED BY THE NURSING STAFF, WHO REPORT THEY NOTED IT WHILST PREPARING FOR A ROLL, AND NOT AFTER NURSING INTERVENTION / INADVERTENT PULLING ETC. NO AIR EMBOLI OR OTHER ACUTE COMPLICATION IS APPARENT."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1684869 | ARROW CVC KIT: 4-LUMEN 8.5FR X 16 CM | CATHETER, PERCUTANEOUS | DQY | ARROW INTERNATIONAL LLC | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | NOT REPORTED| NOT REPORTED |