MAUDE Adverse Event Report: B. BRAUN OF DOMINICAN REPUBLIC ULTRASITE VALVE NEEDLELESS SYSTEM; SMALL BORE EXTENSION SET WITH ULTRASITE

Model Number CSE6TSLB

Device Problems Fluid/Blood Leak (1250); Device Operates Differently Than Expected (2913)

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

Event Date 02/19/2015

Event Type  malfunction  

Event Description

As reported by the user facility: event #3: reports five incidents of leaking blood and nuclear contrast agent at the luer lock ending of the t-port.The reporter stated that upon examination of the luer lock ending, the bore size and circumference appeared larger and wider.

Manufacturer Narrative

This report has been identified as b.Braun medical inc.Internal report # (b)(4).Two used extension sets were received for eval.Packaging returned with both sets indicated the reported lot number # 0061394026.One package was labeled "right"; the other package was labeled "made wrong".No visual differences were noted between the samples.The spin-lock collar on the t-port luer lock endings were connected to a female luer by fully rotating the collar.Both sets were then subjected to an air pressure (leakage) test according to specification with acceptable results.There were no leakages observed from the luer lock ending or from any other location on the sets.The diameters of the spin-lock collar and luer port were dimensionally measured according to specification and found acceptable on both samples.In addition, the luer connectors on the sets met the applicable iso luer gauge specification.Review of the discrepancy management system database performed for the reported lot number did not reveal any abnormalities or nonconformances of this nature.No adverse quality trends of this nature were identified during the complaint review process for the reported catalog number or lot number.Based on the results of this investigation, no specific conclusions can be made regarding the cause of the reported events.The returned samples met specification, and the reported failure could not be reproduced.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: ULTRASITE VALVE NEEDLELESS SYSTEM
• Type of Device: SMALL BORE EXTENSION SET WITH ULTRASITE
• Manufacturer (Section D): B. BRAUN OF DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: eric roden ; km. 22, las americas hwy; parque las americas; santo domingo ; DR ; 5491000
• MDR Report Key: 4632549
• MDR Text Key: 5615259
• Report Number: 9614279-2015-00014
• Device Sequence Number: 1
• Product Code: KGZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K760385
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/19/2015

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: 08/31/2019
• Device Model Number: CSE6TSLB
• Device Catalogue Number: 473449
• Device Lot Number: 0061394026
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/19/2015
• Initial Date FDA Received: 03/20/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• 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