FDA Adverse Event Malfunction Summary report: N

SMITHS MEDICAL CADD CASSETTE RESERVOIR

MDR report key: 9811183 · Received March 10, 2020

Report

Report Number: 3012307300-2020-01918
Event Type: Malfunction
Date Received: March 10, 2020
Date of Event: February 13, 2020
Report Date: July 30, 2020
Manufacturer: SMITHS MEDICAL ASD, INC.
Product Code: FPA
UDI-DI: 10610586027239
PMA / PMN Number: K081156
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: UK
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 0

ADDITIONAL INFORMATION: D10, H6, H10. DEVICE EVALUATION: ONE CADD CASSETTE RESERVOIRS WAS RETURNED FOR ANALYSIS. THE SAMPLE RECEIVED CONSIST OF ONE CASSETTE PRODUCT FORM P/N 21-7302-24 L/N 3882472. THE SAMPLE WAS RECEIVED IN USED CONDITIONS WITHOUT ITS ORIGINAL PACKAGING INSIDE IN A PLASTIC BAG. THE SAMPLE WAS VISUALLY INSPECTED, AT A DISTANCE OF 12" TO 24" AND NORMAL CONDITIONS OF ILLUMINATION AND FOUND THE SAMPLE PRESSURE PLATE DETACHED. FUNCTIONAL TESTING PERFORMED BY USING A SYRINGE TO INFUSE WATER INTO THE AY BAG AND LEAKAGE WAS DETECTED IN THE AY BAG. THE CUSTOMER'S REPORTED PROBLEM WAS CONFIRMED. ACCORDING TO THE INVESTIGATION, THE MOST PROBABLE ROOT CAUSE OF THE REPORTED PROBLEM IS THAT, DURING LEAK TESTING OPERATION THE CASSETTE'S THAT FAILED (LEAK TEST), WERE NOT PROPERLY SEGREGATED. THE PROBLEM SOURCE OF THE REPORTED PROBLEM IS MANUFACTURING.

Description of Event or Problem · 1

INFORMATION WAS RECEIVED THAT WHILE A SMITHS MEDICAL CADD CASSETTE RESERVOIR CASSETTE IS LEAKING. THE CUSTOMER IS UNABLE TO ASCERTAIN THE LOCATION OF THE LEAK. NO PATIENT INVOLVEMENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
276689	SMITHS MEDICAL CADD CASSETTE RESERVOIR	SET, ADMINISTRATION, INTRAVASCULAR	FPA	SMITHS MEDICAL ASD, INC.	21-7302-24	3882472	10610586027239

Patients

Seq	Age	Sex	Outcome	Treatment
1