FDA Adverse Event Malfunction Summary report: N

TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI

MDR report key: 11313329 · Received February 11, 2021

Report

Report Number: 9617594-2021-00041
Event Type: Malfunction
Date Received: February 11, 2021
Date of Event: January 5, 2021
Report Date: January 5, 2021
Manufacturer: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
Product Code: DRS
UDI-DI: 00840619037017
PMA / PMN Number: K061573
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: TW
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

ONE USED. LIST #011-12584-05, TRANSPAC¿ IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRIP; LOT #4935741 WAS RETURNED FOR EVALUATION. THE REPORTED COMPLAINT OF TUBING DETACHED WAS CONFIRMED ON THE RETURNED SET. AN IMAGE WAS PROVIDED BY THE CUSTOMER SHOWING THE AREA OF THE DEFECT. DURING VISUAL INSPECTION, THE 12" PRESSURE TUBING WAS FOUND SEPARATED FROM THE WINGED MALE LUER. THE PRESSURE TUBING WAS FOUND TACKY AT THE BOND SITE. THE SEPARATION OF THE BOND WAS DUE TO THE PRESSURE TUBING BEING TACKY. THE PROBABLE CAUSE OF THE PRESSURE TUBING BEING TACKY IS DUE TO THE TUBING NOT BEING FULLY CURED DURING ASSEMBLY PROCESS. A REPRESENTATIVE BOND WAS PULLED AND THE TUBING BROKE NEAR THE LUER WITHIN THE SPECIFICATIONS. THE LOT HISTORY WAS REVIEWED AND NO NONCONFORMITIES WERE IDENTIFIED THAT MAY HAVE CONTRIBUTED TO THE REPORTED COMPLAINT.

Description of Event or Problem · 1

THE EVENT INVOLVED A TRANSPAC IV MONITORING KIT THAT WAS REPORTED THAT THE TUBING DETACHED FROM THE KIT. THERE WAS NO REPORT OF ADVERSE EVENT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
212564	TRANSPAC IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI	TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR	DRS	ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.		4935741	00840619037017

Patients

Seq	Age	Sex	Outcome	Treatment
1