FDA Adverse Event Malfunction Summary report: N

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

MDR report key: 12484923 · Received September 16, 2021

Report

Report Number: 3014704491-2021-00140
Event Type: Malfunction
Date Received: September 16, 2021
Date of Event: August 10, 2021
Report Date: September 3, 2021
Product Code: FOZ
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 1050046. ACCORDING TO THE SAMPLING PLAN APPLIED FOR PRODUCT PERFORMANCE, THIS LOT WAS ACCEPTED AND RELEASED WITHOUT DEFECTS BEING NOTED DURING THE FINAL ASSEMBLY OR VISUAL INSPECTIONS. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, FUNCTIONAL TESTING WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RESULTS OF THESE SHOW THAT THE TESTED UNITS PERFORMED WITHIN PRODUCT SPECIFICATIONS. UNFORTUNATELY WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT.

Description of Event or Problem · 1

IT WAS REPORTED WHEN USING THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM THERE WAS A DAMAGED/DEFORMED PRODUCT - DEVICE IS OPERABLE AND THERE WAS LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. THE CUSTOMER STATED: "THE Y-SHAPED INDWELLING NEEDLE WAS USED TO CONNECT THE INFUSION CONNECTOR FOR FLUID REHYDRATION. LEAKAGE WAS FOUND AFTER USE. THE INDWELLING NEEDLE WAS INSPECTED AND CRACKS WERE FOUND IN THE PLASTIC JOINT. THE INDWELLING NEEDLE WAS REPLACED IN WITHOUT SERIOUS ADVERSE CONSEQUENCES."

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1379579	BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM	INTRAVASCULAR CATHETER	FOZ			1050046

Patients

Seq	Age	Sex	Outcome	Treatment
1