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

Catalog Number FMC9682P

Device Problem Air Leak (1008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/14/2014

Event Type  malfunction  

Event Description

It was reported that a clearlink vented blood administration set had air bubbles in the infusion line.This was observed during flushing of the iv with meropenem with normal saline via baxter pump.There was no patient injury or medical intervention associated with this event.Additional information was requested and is not available.

Manufacturer Narrative

(b)(4).(b)(6).If the sample becomes available for evaluation or any relevant information is obtained that is related to the reported event, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation and the lot number is unknown; therefore, a device analysis could not be performed.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: 3928368
• MDR Text Key: 4530788
• Report Number: 1416980-2014-22198
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/17/2014

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 Catalogue Number: FMC9682P
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: MEROPENEM WITH NORMAL SALINE; BAXTER PUMP