FDA Adverse Event Malfunction Summary report: N

ARROW ARTERIAL LINE KIT

MDR report key: 3973071 · Received July 22, 2014

Report

Report Number
3973071
Event Type
Malfunction
Date Received
July 22, 2014
Date of Event
July 17, 2014
Report Date
July 22, 2014
Manufacturer
TELEFLEX MEDICAL
Product Code
DQO
Product Problem
Yes
Report Source
User Facility report
Reporter Location
MI, US

Narratives

Description of Event or Problem · 1

PT WAS A NEW TRAUMA WITH MULTIPLE BROKEN BONES. IN ER, FOUR LUMEN CENTRAL LINE PLACED TO THE RT GROIN THAT FOLDED BACK ON ITSELF. FOUR LUMEN CENTRAL LINE THEN PLACED IN THE RIGHT SUBCLAVIAN WITH MUCH DIFFICULTY. PT HAD LOW BLOOD PRESSURE AND FEMORAL PULSE THAT WAS WEAK. RESIDENT ATTEMPTED FEMORAL ARTERIAL LINE AND UNABLE TO THREAD WIRE. ATTENDING ATTEMPTED ARTERIAL LINE MULTIPLE TIMES AND UNABLE TO THREAD WIRE THROUGH NEEDLE. ONCE WIRE WAS THREADED THEN UNABLE TO ADVANCE CATHETER OVER WIRE INTO THE SITE. HAD GOOD ARTERIAL FLOW, WIRE ATTEMPTED BOTH WAYS AND STILL UNABLE TO ADVANCE WIRE. NEW KIT OBTAINED, WIRE ADVANCED EASILY WITH NEW WIRE. ATTEMPTED TO INSERT OLD WIRE INTO NEEDLE FROM NEW KIT ONCE LINE PLACED AND DRESSED. WIRE VERY HARD TO INSERT BUT COULD FORCE THROUGH X 1. WIRE SAVED.ARROW ARTERIAL LINE KIT, LOT NUMBER 23F14E1034. AFTER THE DOCTOR GOT THE NEEDLE INTO THE ARTERY THE WIRE WOULD NOT ADVANCE. MUCH WORK GETTING IT INTO THE ARTERY; BUT WHEN A NEW WIRE WAS USED IT THREADED EASILY.ADDITIONAL INFO FROM THE RN INVOLVED IN THE CASE: BOTH KITS (THE ONE THAT WORKED AND THE ONE THAT DIDN'T WORK) HAD THE SAME LOT #S. THE RN THINKS THE INCIDENT IS PART FROM THE ANATOMY OF THE PATIENT BECAUSE ALL EXTEMITIES WERE BROKEN IN THE TRAUMA EVENT, INCLUDING RIBS AND PELVIS. HOWEVER, THE RN ALSO THINKS THE WIRE COULD BE DEFECTIVE.======================MANUFACTURER RESPONSE FOR FEMORAL ARTERIAL LINE, (BRAND NOT PROVIDED) (PER SITE REPORTER).======================WE HAVE NOT HEARD BACK FROM THEM.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
427421 ARROW ARTERIAL LINE KIT PERCUTANEOUS ATRIAL CATHETER KIT DQO TELEFLEX MEDICAL * 23F14E1034
427505 ARROW ARTERIAL LINE KIT PERCUTANEOUS ATRIAL CATHETER KIT DQO TELEFLEX MEDICAL * 23F14E1034

Patients

Seq Age Sex Outcome Treatment
1 42 YR OTHER