FDA Adverse Event Malfunction Summary report: N

TR BAND

MDR report key: 2834205 · Received November 15, 2012

Report

Report Number: 9681834-2012-00067
Event Type: Malfunction
Date Received: November 15, 2012
Date of Event: September 12, 2012
Report Date: September 12, 2012
Manufacturer: TERUMO CORPORATION, ASHITAKA
Product Code: DXC
PMA / PMN Number: K070423
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: CT, US
Reporter Occupation: PHYSICIAN

Narratives

Additional Manufacturer Narrative · 1

THE INVOLVED DEVICE WAS NOT RETURNED FOR EVALUATION AND THE LOT NUMBER IS NOT KNOWN. THEREFORE, MEANINGFUL EVALUATION OF DEVICE HISTORY RECORDS AND COMPLAINT FILES IS NOT POSSIBLE. HOWEVER, A SAMPLE OF THE REPORTED PRODUCT CODE FROM CURRENT PRODUCTION WAS EVALUATED. INSPECTION AND TESTING OF THE SAMPLE FROM THE CURRENT PRODUCTION RUN CONFIRMED THAT THERE WERE NO DEFECTS OR ANOMALIES. THE CAUSE FOR THE REPORTED FAILURE OF THE TR BAND CANNOT BE DETERMINED BASED UPON THE CURRENTLY AVAILABLE INFORMATION. THE LABELING DOES ADDRESS THE POTENTIAL FOR SUCH A DEFLATION EVENT IN THE INSTRUCTIONS-FOR-USE WITH STATEMENTS SUCH AS: "BE CAREFUL THAT NO FOREIGN PARTICLES GET INTO THE AIR INJECTION PORT WHEN INJECTING THE AIR. THE AIR COULD LEAK"; AND "PATIENT SHOULD NOT BE LEFT UNATTENDED WHILE THE TR BAND IS IN USE." AS OF THIS TIME, REPEATED ATTEMPTS TO OBTAIN THE SAMPLE AND/OR FOLLOW UP INFORMATION HAVE BEEN UNSUCCESSFUL. ALL CURRENTLY AVAILABLE INFORMATION HAS BEEN FILED BY QA AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. (B)(4).

Description of Event or Problem · 1

(B)(4) WHICH WAS RECEIVED FROM THE FDA ON (B)(4) 2012: THE "TR BAND FAILED". REPEATED ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	TR BAND	VASCULAR CLAMP	DXC	TERUMO CORPORATION, ASHITAKA	NA	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1