MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU LURE ADAPTER; TUBES

Catalog Number XX*MN2000T

Device Problem Use of Device Problem (1670)

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

Event Date 11/11/2014

Event Type  malfunction  

Event Description

The user facility reported a needle stick from a luer adapter device.Follow up communication with the user facility reported: the luer adapter broke into 3 pieces while the tubes were being drawn; this resulted in a puncture with the needle to right thumb while trying to reattach; the nurse was sent for tetanus and observation; and the tubes had to be re-drawn.

Manufacturer Narrative

The actual device was not returned to the manufacturing facility and evaluated.Therefore, the investigation consisted of a review of retention samples, user facility information and manufacturer quality records.Visual inspection of the retention sample found no abnormalities.A review of the device history record and manufacturing inspection record confirmed that there were no production related problems.Although the cause of the reported event cannot be definitively determined based upon the available information, there is no evidence that this event was related to a device defect or malfunction.All available information has been placed on file in quality assurance at the manufacturing facility for appropriate tracking, trending, and follow-up.(b)(4).Device not returned.

• Brand Name: LURE ADAPTER
• Type of Device: TUBES
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409- 3583; JA 409-3583
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409- 3583; JA 409-3583
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4326478
• MDR Text Key: 5240713
• Report Number: 9681835-2014-00029
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K983490
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2014,12/12/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2016
• Device Catalogue Number: XX*MN2000T
• Device Lot Number: 140317A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 11/11/2014
• Device Age: 8 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/13/2014
• Date Manufacturer Received: 11/13/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/16/2014
• 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