MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC IV ADMINISTRATION SET; IV ADMIN SET W/ 2 SAFSITE INJ SITES

Model Number PB152VSL

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

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

Event Type  malfunction  

Event Description

As reported by the user facility: reports on ongoing issue with the valves sometimes leaking after being accessed or when removing the blue cap.The samples were not saved since they contained chemo.The reporter indicated there have been approximately 1 out of 100 per day (estimate have had about 70).The facility continues to use the sets and have been controlling any leaks by closing off and adding a safeday valve.

Manufacturer Narrative

(b)(4).The actual device involved in the reported incident was not returned for evaluation.Without the actual sample, a thorough evaluation could not be performed and no specific conclusions can be drawn.Remaining inventory of the involved safsite valve lot ((b)(4)) was pulled for evaluation and visually inspected for any damages.There were no damages or abnormalities observed.In addition, (b)(4) random samples were then subjected to functional testing (including leakage and weepage after accessing the valve) according to specification with acceptable results.There were no leakages observed.Review of the discrepancy managements 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.If additional pertinent information becomes available, a follow-up report will be filed.

• Brand Name: IV ADMINISTRATION SET
• Type of Device: IV ADMIN SET W/ 2 SAFSITE INJ SITES
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; km. 22 autopista las americas; santo domingo ; DR ; 8095491000
• MDR Report Key: 3963961
• MDR Text Key: 16185335
• Report Number: 9614279-2014-00024
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K954123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2019
• Device Model Number: PB152VSL
• Device Catalogue Number: 351559
• Device Lot Number: 0061349602
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/23/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2014
• 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