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

Catalog Number EMC9675

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 01/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual device was not available; however, a retained sample was evaluated.The sample was visually inspected and no issues were found.The reported condition was not verified.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.

Event Description

It was reported that an access administration set had a connection issue during set-up, before patient use.According to the report, a syringe was attached to the set, twisting in place, until the syringe hub was twisted off of the device and became lodged into the set.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(4).(b)(6).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: 4466068
• MDR Text Key: 13078071
• Report Number: 1416980-2015-03670
• Device Sequence Number: 1
• Product Code: BRZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 01/06/2015

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 Expiration Date: 06/30/2019
• Device Catalogue Number: EMC9675
• Device Lot Number: 14G03V003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2015
• Initial Date FDA Received: 01/29/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/25/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/02/2014
• 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