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

Catalog Number FMC9673

Device Problems Kinked (1339); Failure to Prime (1492)

Patient Problem No Patient Involvement (2645)

Event Date 12/01/2014

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Additional information: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was received for evaluation.Visual inspection revealed a kink at the tubing under the vented blood chamber; the walls of the tubing were found to be stuck together due to an excess of solvent.A flow test was performed, and solution did not flow through the kink.The reported condition was verified.The cause of the condition was determined to be a solvent application failure during the manufacturing process that led to excess solvent causing a blockage of flow.A capa has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a blood administration set was unable to prime.It was noted that there was a kink below the drip chamber.This was observed during priming.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4503981
• MDR Text Key: 13114670
• Report Number: 1416980-2015-05106
• 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: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/14/2015

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: Other
• Device Catalogue Number: FMC9673
• Device Lot Number: 14F24V715
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/04/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/06/2015
• Initial Date FDA Received: 02/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/26/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/09/2014
• 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