FDA Adverse Event Malfunction Summary report: N

STREAMLINE ISS IV POLE

MDR report key: 8510321 · Received April 12, 2019

Report

Report Number: 1825014-2019-00001
Event Type: Malfunction
Date Received: April 12, 2019
Date of Event: March 14, 2019
Report Date: April 12, 2019
Manufacturer: COMDEL INNOVATION
Product Code: FOX
Product Problem: Yes
Report Source: Distributor report
Reporter Location: MI, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 1

MANUFACTURER RECORDS INVESTIGATION SHOWS THAT A DESIGN REVISION TOOK PLACE ON 4/25/14 WHERE THE SPOT TYPE WELD WAS CHANGED TO A FULL 360 DEGREE WELD AT THIS CONNECTION POINT. THE MANUFACTURER RECORDS SHOW THAT POLES SHIPPED BEFORE THIS REVISION WOULD HAVE THE SPOT WELD. THERE ARE 8 POLES THAT SHIPPED BEFORE THE REVISION AND THE SHIP TO LOCATION OF EACH HAS BEEN IDENTIFIED. TWO POLES HAVE BEEN RETURNED FROM THE HOSPITAL WHERE THE COMPLAINT ORIGINATED. THESE ARE NOW ON HOLD AT (B)(4) AND WILL BE RETURNED TO THE MANUFACTURER, COMDEL. THREE POLES ARE ON-SITE AT THE MANUFACTURER, COMDEL, AND WILL BE REWORKED WITH A 360 DEGREE WELD. THREE POLES WERE SHIPPED TO DISTRIBUTORS AS DEMO MODELS. THE MANUFACTURER WILL SHIP REPLACEMENT POLES TO THESE DISTRIBUTORS AND THE AFFECTED POLES WILL BE RETURNED TO THE MANUFACTURER TO BE REWORKED WITH A 360 DEGREE WELD.

Description of Event or Problem · 1

A USER AT A HOSPITAL IDENTIFIED THAT A IV STREAMLINE POLE AND WING BARS WERE TILTED ON THE STAND. INSPECTION FOUND THE CONNECTION POINT BETWEEN THE BASE AND THE TREE SECTION WAS LOOSE. FURTHER INSPECTION FOUND THAT THE 4 VERY SMALL SPOT WELDS HAD BROKE LOOSE WHICH IS WHY IT CREATED A LOOSE FITTING FOR THE IV WING BAR SYSTEM. IV POLE WAS TAKEN OUT OF SERVICE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
300510	STREAMLINE ISS IV POLE	IV POLE	FOX	COMDEL INNOVATION	ISS-NW

Patients

Seq	Age	Sex	Outcome	Treatment
1