FDA Adverse Event Other Summary report: N

FAST1 INTRAOSSEOUS INFUSION SYSTEM

MDR report key: 1461702 · Received June 10, 2009

Report

Report Number: 9615387-2009-00017
Event Type: Other
Date Received: June 10, 2009
Date of Event: January 1, 2007
Report Date: June 10, 2009
Manufacturer: PYNG MEDICAL CORP.
Product Code: FMI
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CA
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THIS PRODUCT DOES NOT HAVE A 510(K) NUMBER. (B) (4). AN ANALOGOUS PRODUCT SOLD IN THE U.S. HAS 510 (K) NUMBER K970380. THE FAST1 INFUSION TUBE IS ONLY INTENDED FOR USE FOR UP TO 24 HOURS. ITS USE FOR UP TO 3 WEEKS HAS NOT BEEN SUBSTANTIATED. DESPITE SEVERAL PHONE CALLS AND A LETTER SENT TO THE ICU, NO FURTHER INFO WAS FORTHCOMING. NO FURTHER FOLLOW-UP COULD BE OBTAINED.

Description of Event or Problem · 1

REMOVAL ISSUE. PYNG MEDICAL GOT A CALL FROM THE REGISTRAR OF THE ICU OF A LOCAL HOSPITAL REGARDING GA PT WHO HAD SUCCESSFULLY RECEIVED INTRAOSSEOUS INFUSION USING THE FAST1, "TWO TO THREE WEEKS" PREVIOUSLY. THE REGISTRAR WAS REPORTING THAT THE FLEXIBLE PORTION OF THE TUBING HAD BECOME SEPARATED FROM THE PORTAL LEAVING THE PORTAL TIP BEHIND IN THE PT'S STERNUM. THEY DID NOT KNOW HOW IT SEPARATED. THE REGISTRAR WAS SEEKING INFO ON THE MATERIALS OF THE PORTAL TIP AND SUGGESTED METHODS OF REMOVAL OF THE PORTAL TIP. THE REASON WHY THE INFUSION TUBE REMAINED IN THE PT, AND THE SURGEON WAITED 2-3 WEEKS BEFORE CONTACTING PYNG MEDICAL, WAS BECAUSE THE PT HAD COAGULOPATHY AND, THEREFORE, COULD NOT UNDERGO SURGERY DUE TO EXCESSIVE BLEEDING. THE INFUSION TUBE IS INTENDED FOR USE ONLY FOR UP TO 24 HOURS. (B) (4).

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	FAST1 INTRAOSSEOUS INFUSION SYSTEM		FMI	PYNG MEDICAL CORP.	01-0017-001

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other