MAUDE Adverse Event Report: BECTON DICKINSON BD Q-SYTE LUER ACCESS SPLIT-SEPTUM DEVICE

Catalog Number 385100

Device Problem Leak/Splash (1354)

Patient Problem Burn(s) (1757)

Event Date 12/10/2014

Event Type  Injury  

Event Description

It was reported that while in a hosp a pt was receiving a chemotherapy infusion.During the infusion, the nurse discovered the chemotherapy was leaking at the luer connection of the bd q-syte device and that the pt obtained a skin burn.The pt's skin burn was treated with medication while in the hosp and the pt was discharged home.

Manufacturer Narrative

A sample is available for eval and is currently being decontaminated.Upon completion of the investigation, a supplemental report will be filed.

• Brand Name: BD Q-SYTE LUER ACCESS SPLIT-SEPTUM DEVICE
• Type of Device: LUER ACCESS SPLIT-SEPTUM
• Manufacturer (Section D): BECTON DICKINSON; 1 becton dr.; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; blvd luis donaldo colosio #579; nogales, sonora 8404 8; MX 84048
• Manufacturer Contact: aaron larson ; 1 becton dr.; franklin lakes, NJ 07417 ; 8015652406
• MDR Report Key: 4428047
• MDR Text Key: 5371282
• Report Number: 2243072-2015-00006
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2019
• Device Catalogue Number: 385100
• Device Lot Number: 4128924
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/29/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/18/2014
• Initial Date FDA Received: 01/12/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/01/2014
• 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
• Patient Outcome(s): Required Intervention