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

Catalog Number VMC9607C

Device Problems Leak/Splash (1354); Chemical Spillage (2894)

Patient Problem No Patient Involvement (2645)

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported that a light sensitive drug set had a leak in the segment that goes into the infusion pump for administration of parenteral nutrition.There was no patient involvement as this occurred before patient use.No additional information is available.This medical device report is report 2 of 3.

Manufacturer Narrative

(b)(4).(b)(6).A batch review will be performed.Should the device be received or any other relevant information be obtained that is related to the reported event, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Evaluation summary: the actual device was not returned; however, a retention sample was evaluated.Visual inspection was performed with no issues noted.A gravity test was performed with liquid correctly flowing through the tubing.The reported condition was unable to be verified for the retention sample.A review of all batch record documents was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: ACCESS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 3814140
• MDR Text Key: 4403154
• Report Number: 1416980-2014-15706
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: VMC9607C
• Device Lot Number: 13I21V682
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/11/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2013
• 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