FDA Adverse Event Malfunction Summary report: N

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

MDR report key: 8302383 · Received February 4, 2019

Report

Report Number: 3006948883-2019-00121
Event Type: Malfunction
Date Received: February 4, 2019
Date of Event: January 17, 2019
Report Date: January 22, 2019
Manufacturer: BD (SUZHOU)
Product Code: FOZ
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: NURSE

Narratives

Additional Manufacturer Narrative · 1

INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED BY YOUR FACILITY A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 8043038. OUR RECORDS SHOW THAT THIS IS THE ONLY INSTANCE OF THIS ISSUE OCCURRING IN THIS PRODUCTION BATCH. 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. UNFORTUNATELY A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT, OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. BD WILL CONTINUE TO MONITOR THIS ISSUE AND ENCOURAGES YOU TO SUBMIT YOUR SAMPLE FOR REVIEW. INVESTIGATION CONCLUSION: UNCONFIRMED: BD WAS NOT ABLE TO DUPLICATE OR CONFIRM THE CUSTOMER'S INDICATED FAILURE MODE AS NO PHOTOS OR SAMPLES WERE RETURNED. ROOT CAUSE DESCRIPTION: THE ROOT CAUSE CANNOT BE DETERMINED. RATIONALE: NO CAPA IS REQUIRED AT THIS TIME.

Description of Event or Problem · 1

IT WAS REPORTED THAT THE BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM LEAKED FROM THE TUBING AT THE Y-CONNECTOR DURING USE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
94440	BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM	INTRAVASCULAR CATHETER	FOZ	BD (SUZHOU)		8043038

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other