MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC INC. CARESITE® (LAD) SYSTEM; CARESITE SMALLBORE EXTENSION SET

Catalog Number 470106

Device Problems Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem No Information (3190)

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Six used caresite smallbore extension sets were received for evaluation.Packaging returned with the samples indicated lot number 0061446132.One of the returned sets was identified as containing chemo.The caresite smallbore extension set (catalog # 470106) contains two caresite valves per set.On five of the six returned sets (including the set identified as containing chemo), a crack was observed on the female luer threads of the molded caresite body on one of the two caresite valves contained on each set.The cracks started from the top of the valve and extended down to the bottom of the luer threads.No cracks or other anomalies were visually observed on the sixth remaining set.This set was then subjected to leakage testing according to specification with acceptable results.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.Although a definitive conclusion could not be made regarding the cause of the reported event, cracking of this nature can occur when the product is subjected to aggressive solvents, excessive mechanical stresses, or other various unforeseen circumstances during the clinical application.If additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: reports the caresite bifurcated extension sets are leaking.In one case, a chemo agent was being infused and leaked down the side of the valve.

• Brand Name: CARESITE® (LAD) SYSTEM
• Type of Device: CARESITE SMALLBORE EXTENSION SET
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC INC.; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR
• Manufacturer Contact: eric roden ; las americas industrial park; km22 autopista las americas; santo domingo, dominican republic ; DR ; 5491000
• MDR Report Key: 5293271
• MDR Text Key: 34074171
• Report Number: 9614279-2015-00064
• 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: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: 470106
• Device Lot Number: 0061446132
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2015
• 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