FDA Adverse Event Malfunction Summary report: N

HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM

MDR report key: 5090989 · Received September 21, 2015

Report

Report Number: 3006425876-2015-00308
Event Type: Malfunction
Date Received: September 21, 2015
Date of Event: August 28, 2015
Report Date: September 15, 2015
Manufacturer: ARROW INTERNATIONAL INC.
Product Code: LFJ
PMA / PMN Number: K895417
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CI
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

QN#(B)(4). ADDITIONAL INFORMATION: THE REPORTED COMPLAINT COULD NOT BE CONFIRMED BECAUSE NO SAMPLE WAS RETURNED FOR EVALUATION. A REVIEW OF MANUFACTURING RECORDS DID NOT YIELD ANY RELEVANT FINDINGS. THE PROVIDED INSTRUCTIONS DESCRIBE SUGGESTED TECHNIQUES TO MINIMIZE THE LIKELIHOOD OF GUIDE WIRE DAMAGE DURING USE. HOWEVER, THE PROBABLE CAUSE COULD NOT BE DETERMINED BASED UPON THE INFORMATION PROVIDED AND WITHOUT A SAMPLE. NO FURTHER ACTIONS WILL BE TAKEN.

Additional Manufacturer Narrative · 1

(B)(4). THIS REPORT IS FOR THE FIRST IN A SERIES OF TWO CONSECUTIVE PRODUCT ISSUES WITH THE SAME PATIENT. THE SECOND EVENT HAS BEEN REPORTED UNDER MDR# 3006425876-2015-00309.

Description of Event or Problem · 1

IT WAS REPORTED THE CATHETER WAS BEING PLACED INTO THE RIGHT FEMORAL VEIN OF A PATIENT IN THE INTENSIVE CARE UNIT. AFTER PASSING THE CATHETER OVER THE GUIDE WIRE THEY EXPERIENCED DIFFICULTY WHEN WITHDRAWING THE WIRE AND IT "FRAYED". AS A RESULT, ANOTHER KIT WAS OPENED AND USED. THEY DO NOT KNOW IF THERE WAS A DELAY IN TREATMENT. THE PATIENT HAD LOCAL BLEEDING WITH DIFFICULT CONTAINMENT. NO PATIENT DEATH WAS REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
621970	HEMODIALYSIS SET: 2-LUMEN 12 FR X 16 CM	ACUTE HEMODIALYSIS CATHETER PRODUCTS	LFJ	ARROW INTERNATIONAL INC.		71F14F0632

Patients

Seq	Age	Sex	Outcome	Treatment
1