FDA Adverse Event Malfunction Summary report: N

INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC

MDR report key: 9930231 · Received April 6, 2020

Report

Report Number: 3006948883-2020-00118
Event Type: Malfunction
Date Received: April 6, 2020
Date of Event: March 17, 2020
Report Date: April 27, 2020
Manufacturer: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.
Product Code: FMF
PMA / PMN Number: N/A
Adverse Event: Yes
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CH
Reporter Occupation: OTHER HEALTH CARE PROFESSIONAL

Narratives

Additional Manufacturer Narrative · 0

H.6. INVESTIGATION: A DEVICE HISTORY REVIEW WAS CONDUCTED FOR LOT NUMBER 9141672. 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. THROUGH OBSERVING THE SUBMITTED VIDEO OUR ENGINEERS DETERMINED THAT LEAK IS RELATED TO DAMAGE TO THE ADAPTER, BUT THEY WERE UNABLE TO DETERMINE THE EXACT NATURE OF THE BREACH. WITHOUT THE ABILITY TO INVESTIGATE THE AFFECTED UNIT OUR QUALITY ENGINEERS WERE UNABLE TO DETERMINE THE ROOT CAUSE FOR THIS COMPLAINT. H3 OTHER TEXT : SEE H.10

Description of Event or Problem · 0

IT WAS REPORTED THAT THE INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC EXPERIENCED LEAKAGE DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: AFTER THE PUNCTURE OF THE PRODUCT WAS COMPLETED, WHEN THE SALINE SOLUTION WAS INJECTED, LEAKAGE WAS FOUND BETWEEN THE SEPTUM AND THE NEEDLE SEAT.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
392861	INTIMA-II Y 24GAX0.75IN PRN EC SLM NPVC	INTERVASCULAR CATHETER	FMF	BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.		9141672

Patients

Seq	Age	Sex	Outcome	Treatment
1			Other