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

Catalog Number 470106

Device Problems Crack (1135); Fluid/Blood Leak (1250); Chemical Spillage (2894)

Patient Problem Chemical Exposure (2570)

Event Type  malfunction  

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report (b)(4).Seven used caresite smallbore extension sets, without packaging, were received for evaluation.The caresite smallbore extension set (catalog # 470106) contains two caresite valves per set.On five of the seven returned sets, a crack was observed on the female luer threads of the molded caresite valve 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 other two sets.These two sets were then subjected to leakage testing according to specification with acceptable results.Without the lot number, a thorough evaluation could not be performed.Although the duration of use for the caresite valve could not be confirmed, the initial report from the facility did indicate that this issue seems to occur with chemotherapy that requires longer administration times.Per the instructions for use (ifu) for the reported product catalog number, "caresite lad is compatible with lipid emulsion (contained in tpn solutions) and cytotoxic agents containing cremophor (e.G., paclitaxel) for 24 hours." 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: event # 2: reports there have been nine recent events of chemo leakage due to a crack in the valve area.The issues seem to occur with chemotherapy that requires longer administration times.The facility has switched to the ultrasite valve because of these occurrences.Four of the leakages occurred with methotrexate medication; the chemo medication was unknown for the other five events.

• 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: 5110588
• MDR Text Key: 27178137
• Report Number: 9614279-2015-00036
• 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
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 470106
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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