FDA Adverse Event Malfunction Summary report: N

BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM

MDR report key: 15670298 · Received October 25, 2022

Report

Report Number: 3014704491-2022-00517
Event Type: Malfunction
Date Received: October 25, 2022
Date of Event: September 18, 2022
Report Date: October 21, 2022
Manufacturer: BD (SUZHOU)
Product Code: FOZ
UDI-DI: 00382903830282
PMA / PMN Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL
Health Professional: Yes

Narratives

Additional Manufacturer Narrative · 0

INITIAL REPORTER E-MAIL: UNKNOWN. INVESTIGATION SUMMARY: IN RESPONSE TO THE EVENT REPORTED, A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 2053243. 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. A SAMPLE COULD NOT BE OBTAINED FOR EVALUATION AND TESTING; IN LIEU OF THE AFFECTED DEVICE, VISUAL ANALYSIS WAS PERFORMED ON RETENTION SAMPLES FOR THIS LOT, THE RETAINED DEVICES WERE FOUND TO BE FREE OF ANY DAMAGE OR OTHER ABNORMALITIES. 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 · 0

IT WAS REPORTED THAT AN UNSPECIFIED NUMBER OF BD INTIMA-II¿ CLOSED IV CATHETER SYSTEMS' PACKAGING UNITS HAD ISSUES WITH AIR LEAKAGE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE: "SEVERAL INDWELLING NEEDLES IN THE BOX HAVE AIR LEAKAGE IN PACKAGING".

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
2776963	BD INTIMA-II¿ CLOSED IV CATHETER SYSTEM	INTRAVASCULAR CATHETER	FOZ	BD (SUZHOU)		2053243	00382903830282

Patients

Seq	Age	Sex	Outcome	Treatment
1		Unknown