MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC CARESITE SMALL BORE EXTENSION SETS; SMALLBORE Y-EXTENSION SET W/2 CARESITES

Catalog Number 470106

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

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

Event Date 02/27/2014

Event Type  malfunction  

Event Description

As reported by the user facility: reports the set leaked at the y-site causing a chemo spill.The chemo medication used was methotrexate.

Manufacturer Narrative

This report has been identified as b braun medical inc.(b)(4).The actual device involved in the reported incident was not returned for eval.Without the actual sample, a thorough eval could not be performed and no specific conclusions can be drawn.The dhr record for the reported lot number was reviewed and no non-conformances or abnormalities were noted during in-process or final product inspection.If add'l pertinent info becomes available, a f/u report will be filed.

• Brand Name: CARESITE SMALL BORE EXTENSION SETS
• Type of Device: SMALLBORE Y-EXTENSION SET W/2 CARESITES
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; km. 22, autopista las americas; las americas industrial park; santo domingo ; DR ; 8095491000
• MDR Report Key: 3932290
• MDR Text Key: 18301652
• Report Number: 9614279-2014-00013
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/11/2014

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: Health Professional
• Device Expiration Date: 11/30/2016
• Device Catalogue Number: 470106
• Device Lot Number: 0061345545
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/11/2014
• Initial Date FDA Received: 04/04/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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