FDA Adverse Event Malfunction Summary report: N

MICROCLAVE

MDR report key: 4894487 · Received July 2, 2015

Report

Report Number: 2025816-2015-00079
Event Type: Malfunction
Date Received: July 2, 2015
Date of Event: June 11, 2015
Report Date: June 12, 2015
Manufacturer: ICU MEDICAL, INC.
Product Code: FPA
PMA / PMN Number: K970855
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FL, US
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

PM 06/19/2015 RECEIVED SEVEN (7) NEW B3300, MICROCLAVE NEUTRAL CONNECTOR ONE FROM EACH LOT NUMBER 3049082, 3030290, 3021144, 3046682, 3026903, 3021143 AND 3026902. NO OTHER DEVICES RETURNED. THE SEVEN (7) B3300 DEVICES HAD NO VISIBLE ANOMALIES PRESENT. INVESTIGATION SUMMARY: THE FACILITY WOULD NOT RELEASE THE REPORTED PROBLEM UNIT FOR INVESTIGATION. THE FOLLOWING RESULTS ARE OF LIKE LOTS FROM THE FACILITY. THE REPORTED PRODUCT PROBLEM COULD NOT BE REPLICATED/CONFIRMED. THE SEVEN (7) NEW/UNUSED MICROCLAVE DEVICES DID MEET THE PRODUCT PERFORMANCE SPECIFICATION REQUIREMENTS WITH NO LEAKS FOUND. THERE WERE NO MATING DEVICES RETURNED FOR INVESTIGATION. THE DIRECTIONS FOR USE (DFU) DOES INSTRUCT THAT THE MICROCLAVE IS COMPATIBLE WITH ISO LUERS HAVING AN INTERNAL DIAMETER (ID) BETWEEN 0.062"-0.110". MALE LUERS WITH INTERNAL DIAMETERS ABOVE 0.110" MAY CAUSE DAMAGE TO THE SEAL OF THE MICROCLAVE.

Description of Event or Problem · 1

COMPLAINT RECEIVED STATING "CLINICIAN STATED THAT THE MICROCLAVE WAS LEAKING WHERE IT JOINS WITH THE STOPCOCK. THE CLINICIAN CLARIFIED THAT THE LEAK SEEMED TO BE COMING FROM THE AREA WHERE THE BLUE POLYCARBONATE HOUSING MEETS THE CLEAR LUER LOCK". NO SERIOUS CONSEQUENCES REPORTED OTHER THAN DELAY IN THERAPY.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
433070	MICROCLAVE	MICROCLAVE	FPA	ICU MEDICAL, INC.	B3300	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1	NI