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

Catalog Number SG2-2713

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/26/2014

Event Type  malfunction  

Event Description

The user facility reported that a nurse incurred a needle stick.Follow-up communication with the user facility confirmed; (1) the nurse activated the safety mechanism by pulling up on the cap to engage it; (2) she and another worker heard it click; (3) the nurse then placed the device on the counter with the rest of the wrappers of trash; (4) when the nurse was cleaning up she scooped up the wrapper and needle; (5) this was when the nurse incurred a stick with the infectious needle; and (6) the nurse is reported doing "fine.".

Manufacturer Narrative

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.Visual inspection of representative and current lot samples did not reveal any defects or abnormalities.Function testing on the samples confirmed that performance specifications were met.The production lot number was not provided by the user facility, which prevented review of applicable production or complaint records.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 pre-existing 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) "handle with care to avoid needlesticks"; (2) "keep hands behind the needle at all times during use and disposal"; (3) "for greatest safety, activate the sheath using a one-handed technique"; (4) "if a needle is bent or damaged, no attempt should be made to straighten needle or use the product"; (5) "position sheath approximately 45 degrees to a flat surface.Press down with a firm, quick motion until a distinct audible click is heard"; (6) "visually confirm that the needle is fully engaged under the lock"; and (7) "dispose of used needles and materials following the policies and procedures of your facility as well as federal and local regulations for sharps disposal." all available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).Device not returned.

• 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: 4110751
• MDR Text Key: 21526689
• Report Number: 3003902955-2014-00017
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 08/27/2014,09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SG2-2713
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/26/2014
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2014
• Date Manufacturer Received: 08/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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