FDA Adverse Event Malfunction Summary report: N

CADD ADMINISTRATION SET

MDR report key: 13226929 · Received January 11, 2022

Report

Report Number: 3012307300-2022-00314
Event Type: Malfunction
Date Received: January 11, 2022
Date of Event: December 15, 2021
Report Date: March 21, 2022
Manufacturer: ST PAUL
Product Code: FPA
UDI-DI: 10610586023279
PMA / PMN Number: K974013
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: JA
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TEST WAS PERFORMED. SAMPLE RECEIVED: ONE (1) SAMPLE WERE RECEIVED FROM P/N 21-7106-24 L/N 4101719 IN USED CONDITIONS, WITH ITS ORIGINAL PACKAGING. LEAK TEST: THE SAMPLE WAS TESTED USING A SYRINGE WITH COLORED WATER. RESULTS: DURING THE TEST, SAMPLE A LEAK WERE FOUND BETWEEN THE FILTER AND TUBE. THE COMPLAINT IS CONFIRMED. THE CAUSE OF THE REPORTED PROBLEM WAS TRACED TO THE MANUFACTURING PROCES - LACK OF SOLVENT BY NOT FOLLOWED TO PROCEDURE MP-366 REV.112 ?EXTENSION SET WITH FILTER ASSEMBLY? SECTION 12.0 BOND COILED TUBE ASSEMBLY TO FILTER INLET. AWARENESS NOTIFICATION WAS MADE TO PRODUCTION PERSONNEL IN ORDER TO EXPLAIN THE IMPORTANCE TO ADHERENCE OR FOLLOWING IN THE PROCEDURE MP-366 REV.112 ?EXTENSION SET WITH FILTER ASSEMBLY SECTION 12.0 BOND COILED TUBE ASSEMBLY TO FILTER INLET, BY QUALITY ENGINEER ON (B)(6) 2022.

Description of Event or Problem · 0

INFORMATION WAS RECEIVED INDICATING THAT A PUMP USING A CADD EXTENSION SET WAS LEAKING MEDICAL FLUID FROM THE CONNECTION PART WHILE IN USE. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
687346	CADD ADMINISTRATION SET	SET, ADMINISTRATION, INTRAVASCULAR	FPA	ST PAUL	21-7106-24	4101719	10610586023279

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown