MAUDE Adverse Event Report: BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS ACCESS; SET, BLOOD TRANSFUSION

Catalog Number EMC3363D

Device Problems Difficult to Remove (1528); Material Rupture (1546)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

It was reported that the luer lock of a blood transfusion set would not disconnect from an unknown stopcock.The reporter stated that the nurse had to use a tool to disconnect the set; the luer lock cap ruptured while attempting to disconnect the set.This occurred during disconnection from the patient.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned; therefore, an evaluation could not be conducted.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, BLOOD TRANSFUSION
• Manufacturer (Section D): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou - 2021oued e; tunis ; TS
• Manufacturer (Section G): BIEFFE MEDITAL MANUFACTURING S.A.R.L. TUNIS; route de chebbaou - 2021oued e; tunis ; TS
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3561860
• MDR Text Key: 4079751
• Report Number: 1416980-2014-00870
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 12/18/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: EMC3363D
• Device Lot Number: 13E21V352
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2013
• Initial Date FDA Received: 01/08/2014
• Date Device Manufactured: 05/08/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: UNKNOWN STOPCOCK; UNKNOWN KOCHER CLAMP