MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD2 SAFETY NEEDLE; TERUMO NEOLUS NEEDLE

Catalog Number 102-N251S

Device Problem Use of Device Problem (1670)

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

Event Date 09/30/2014

Event Type  malfunction  

Event Description

The user facility reported a needle stick occurred after the safety mechanism was activated.Follow-up communication with the user facility confirmed; (1) an injection was performed on a patient and the needle was removed; (2) the safety mechanism was activated with the clinician's thumb and seemed engaged; (3) the device was laid on a tray; (4) a staff member picked up the device to put it into a sharps container and was stuck; and (5) no long term treatment will be needed for exposure.

Manufacturer Narrative

The actual device has not been returned for evaluation and the investigation has yet to be completed.A follow-up report will be submitted when the investigation is complete.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).Device not returned.

Manufacturer Narrative

This report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00022 to provide results of the sample evaluation.The involved device was not returned for evaluation.The investigation was based upon assessment of user facility information, evaluation of representative samples and current lot samples.Visually inspection of retention and current lot samples did not reveal any defects or abnormalities.Function testing confirmed that manufacturing performance specifications were met.A review of the device history record confirmed that there were no production related problems for this lot number.Although the cause for the reported event cannot be definitively determined based on the available information, there is no indication that the event was related to a device defect or malfunction.The device labeling does address the potential for such an occurrence in the warnings/cautions and the instructions-for-use with statements such as the following: (1) "position sheath approximately 45 degrees to a flat surface.Press down with a firm, quick motion until a distinct audible click is heard"; and (2) "visually confirm that the needle is fully engaged under the lock".A review of the device history record indicated that there were no production related problems.

Event Description

This report is being submitted as follow-up #1 for mfg.Report # 3003902955-2014-00022 to provide results of the sample evaluation.

• Brand Name: SURGUARD2 SAFETY NEEDLE
• Type of Device: TERUMO NEOLUS NEEDLE
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4214892
• MDR Text Key: 4974847
• Report Number: 3003902955-2014-00022
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: E270462
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/02/2014,10/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 102-N251S
• Device Lot Number: 140721B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/30/2014
• Device Age: 2 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/02/2014
• Date Manufacturer Received: 11/10/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/21/2014
• 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
• Treatment: SYRINGE