MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC SAFELINE NEEDLELESS SYSTEM; SAFELINE SPLIT SEPTUM INJECTION SITE

Catalog Number NF9100

Device Problem Chemical Spillage (2894)

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

Event Date 06/23/2014

Event Type  malfunction  

Event Description

As reported by the user facility: event #1: reports there were two incident of radio-isotope spills which required clean-up.When using a needle to inject radio-isotopes, leakage occurred at the injection site.The reporter stated it does not leak all the time.The facility uses a needle to inject the isotope because at times, when using the blunt cannula, there is some spray-back of the isotope.The facility uses the blunt cannula when injecting saline.

Manufacturer Narrative

(b)(4).The actual devices involved in the reported incident were not returned for evaluation.However, the facility returned twenty-four (24) unopened, unused safeline injection sites from their current inventory.The packaging from all 24 samples indicated the reported lot number 0061349857.The returned safeline injection sites were inserted through the center with a safeline blunt cannula as per the instructions for use (ifu).The injection sites were then pressurized with a syringe filled with water.During this time, there were no leakages or spray-back observed from the injection sites.Based on the information provided by the reporting facility, it was stated that the injection site was accessed with a needle.Per the ifu, the safeline injection site is intended to be used with the b.Braun safeline system.The septum of the safeline injection site contains a pre-pierced slit and is designed to be used with a safeline cannula.The safeline cannula is to be inserted to the appropriate device through the center of the septum.This device is not intended to be used with a needle.Medication additions requiring a conventional needle should be used in emergency situations only.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature noted during in-process or final product inspection.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.There were no other reports of this nature against the reported lot number.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: SAFELINE NEEDLELESS SYSTEM
• Type of Device: SAFELINE SPLIT SEPTUM INJECTION SITE
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; las americas hwy, km. 22; autopista las americas; santo domingo ; DR ; 5491000
• MDR Report Key: 4009405
• MDR Text Key: 21721355
• Report Number: 9614279-2014-00036
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K931377
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: NF9100
• Device Lot Number: 0061349857
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/08/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/24/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2013
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1