MAUDE Adverse Event Report: B. BRAUN MEDICAL INC. CARESITE® (LAD) SYSTEM; CARESITE LUER ACCESS DEVICE

Catalog Number 415126

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

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The actual devices involved in the reported incident were not returned for evaluation.Incidents of cracked/leaking valves can be caused by many factors, including but not limited to an excess torque force in combination with over-tightening the connection; if the product is subjected to aggressive solvents, excessive mechanical stresses, or other various unforeseen circumstances during the clinical application.However without the actual sample, a thorough sample analysis could not be performed and no specific conclusions can be drawn.Review of the discrepancy management system database performed for the reported lot numbers did not reveal any abnormalities or nonconformances of this nature.If the physical sample is received or if additional pertinent information becomes available, a follow-up report will be filed.

Event Description

As reported by the user facility: event # 4: reports several incidents of cracked caresite valves.On 01/28/2016, additional information was received from the reporting facility indicating that five of the cracked valves led to leakage of chemo medication during infusion.Involved lot numbers: 0061374196 - manufacture date: 05/29/2014; expiration date: 04/30/2017; 0061393032 - manufacture date: 09/08/2014; expiration date: 08/31/2017; 0061431332 - manufacture date: 04/27/2015; expiration date: 03/31/2018; 0061398887 - manufacture date: 10/27/2014; expiration date: 09/30/2017.

Manufacturer Narrative

(b)(4).Twenty-five (25) used sets and fifty-three (53) unused sets were received for evaluation.All twenty-five (25) used sets were leakage tested per specification, and no nonconformances were noted.Ten (10) of the unused samples were leakage tested per specification, and no nonconformances were noted.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported event.The returned set met requirements according to specification, and the reported failure could not be reproduced.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/drugs, excessive mechanical stresses (over-tightening), or other various unforeseen circumstances during the clinical application.If additional pertinent information becomes available a follow-up report will be filed.

• Brand Name: CARESITE® (LAD) SYSTEM
• Type of Device: CARESITE LUER ACCESS DEVICE
• Manufacturer (Section D): B. BRAUN MEDICAL INC.; 901 marcon blvd.; allentown PA 18109
• Manufacturer Contact: jonathan severino ; 901 marcon blvd; allentown, PA 18109-9431 ; 4842408332
• MDR Report Key: 5456435
• MDR Text Key: 39347650
• Report Number: 2523676-2016-00059
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K083723
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 415126
• Device Lot Number: SEE SECTION B5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2017
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/28/2016
• 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