MAUDE Adverse Event Report: B. BRAUN DOMINICAN REPUBLIC CARESITE SMALL BORE EXTENSION SETS; SMALLBORE Y-EXTENSION SET W/ 2 CARESITES

Catalog Number 470106

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: event #3: reports had five sets leak at the body of the valve, but unsure of the exact location.The sets leaked chemo.

Manufacturer Narrative

(b)(4).Five used caresite y-extension sets, and one opened package identifying the reported lot # 0061276549, were received for evaluation.The y-extension set (catalog #470106) contains two caresite valves per set.On the first sample, one of the caresite valves was observed to be broken off at the bonded joint of the female adapter.It appears the valve was subjected to an excessive force which likely caused the valve to break off.On the second, third, and fourth samples, 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.On the fifth sample, no cracks were observed on either caresite valve of the set.However, a separate caresite valve was attached to the spinlock adapter at the distal end of the set.This valve contained a crack on the female luer thread of the molded caresite valve body.The dhr record for the reported lot number was reviewed and no nonconformances or abnormalities were noted during in-process or final product inspection.Although the duration of use for the caresite valve could not be confirmed, it is indicated on the instructions for use (ifu) for the reported product catalog number, "the caresite luer access device is compatible with lipid emulsion and cytotoxic agents containing cremophor (e.G.Pacitaxel) for 24 hours." based on the results of this investigation, no conclusions can be made regarding the cause of the reported events.If additional pertinent info becomes available, a follow-up report will be filed.

• Brand Name: CARESITE SMALL BORE EXTENSION SETS
• Type of Device: SMALLBORE Y-EXTENSION SET W/ 2 CARESITES
• Manufacturer (Section D): B. BRAUN DOMINICAN REPUBLIC; santo domingo ; DR
• Manufacturer Contact: felipe sandoval ; las americas industrial park; km22 autopista las americas; santo domingo ; DR ; 5491000
• MDR Report Key: 3850806
• MDR Text Key: 4617388
• Report Number: 9614279-2014-00009
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2015
• Device Catalogue Number: 470106
• Device Lot Number: 0061276549
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 03/03/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/26/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2012
• 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
• Patient Outcome(s): Other