FDA Adverse Event Malfunction Summary report: N

ACCESS

MDR report key: 3760141 · Received April 18, 2014

Report

Report Number: 1416980-2014-12721
Event Type: Malfunction
Date Received: April 18, 2014
Date of Event: March 24, 2014
Report Date: March 25, 2014
Manufacturer: BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: BR
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

(B)(4). A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE ACTUAL DEVICE WAS NOT RETURNED; THEREFORE, AN EVALUATION ON THE AFFECTED DEVICE COULD NOT BE CONDUCTED. HOWEVER, AN EVALUATION WAS PERFORMED ON A RESERVED SAMPLE (VISUAL INSPECTION AND GRAVITY USE-TESTING). THE DEVICE OPERATED WITHIN THE DESIRED PRODUCT SPECIFICATIONS AND NO ISSUES WERE NOTED DURING THE EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Additional Manufacturer Narrative · 1

(B)(4). (B)(6). A BATCH REVIEW WILL BE PERFORMED. IF ANY RELEVANT INFORMATION IS OBTAINED THAT IS RELATED TO THE REPORTED EVENT, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

Description of Event or Problem · 1

IT WAS REPORTED THAT A LIGHT SENSITIVE DRUG SET HAD A TINY HOLE. THE REPORTER STATED THAT THE HOLE WAS OBSERVED TO LET AIR ENTER THE PRODUCT. THIS WAS OBSERVED BEFORE USE AND THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE. THIS IS REPORT 2 OF 3.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
237098	ACCESS	SET, ADMINISTRATION, INTRAVASCULAR	FPA	BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS		13K13V374

Patients

Seq	Age	Sex	Outcome	Treatment
1