FDA Adverse Event Malfunction Summary report: N

CADD

MDR report key: 13002644 · Received December 14, 2021

Report

Report Number: 3012307300-2021-12251
Event Type: Malfunction
Date Received: December 14, 2021
Date of Event: November 5, 2021
Report Date: March 18, 2022
Manufacturer: ST PAUL
Product Code: FPA
UDI-DI: 10610586023279
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: FR
Reporter Occupation: OTHER
Health Professional: N

Narratives

Additional Manufacturer Narrative · 0

H6: EVENT PROBLEM AND EVALUATION CODES: UPDATED AFTER DEVICE EVALUATION H10: DEVICE EVALUATION: THE DEVICE WAS RETURNED FOR INVESTIGATION. A FUNCTIONAL TESTING WAS PERFORMED. SAMPLE RECEIVED: ONE (1) SAMPLE WERE RECEIVED FROM P/N 21-7106-24 L/N 4101719 IN NEW CONDITIONS, WITHOUT 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 PROCESS, ROOT CAUSE IS LACK OF SOLVENT BY NOT FOLLOWING THE MANUFACTURING PROCEDURE. 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 25/JAN/2022.

Description of Event or Problem · 0

IT WAS REPORTED THAT A SMITHS MEDICAL ADMIN SET HAD A LEAK BETWEEN THE FILTER JUNCTION AND THE REST OF THE TUBING OCCURRED AS SOON AS THE TUBING WAS INSERTED. THE PATIENT CHANGED THE EXTENSION SET AND RETURNED TO NORMAL. NO ADVERSE PATIENT EFFECTS WERE REPORTED.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1901145	CADD	SET, ADMINISTRATION, INTRAVASCULAR	FPA	ST PAUL	21-7106-24	4101719	10610586023279

Patients

Seq	Age	Sex	Outcome	Treatment
1	33 YR	Female