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

Catalog Number SG2-2516

Device Problem Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/17/2014

Event Type  malfunction  

Event Description

The user facility reported a needle stick due to safety device not engaged.Follow-up communication with the user facility confirmed; (1) the nurse was administering tdap; (2) the nurse attempted to lock the safety cap using the table top; (3) a click was herd click and device was put in the sink; (4) the nurse went back she found the device not engaged and stuck herself; (5) the nurse stated the needle was bent sideways, but was not protruding through the cap; and (5) there was no issues as a result of needle stick.

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

The involved device was not returned for evaluation.Visually inspection of retention and current lot samples did not reveal any defects or abnormalities.Function testing confirmed that performance specifications were met.A review of the device history record indicated 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.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.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).

Event Description

(b)(4).

• 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: 4163472
• MDR Text Key: 4785368
• Report Number: 3003902955-2014-00020
• 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,Followup,Followup
• Report Date: 09/12/2014,10/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2018
• Device Catalogue Number: SG2-2516
• Device Lot Number: 130930B
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/17/2014
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/12/2014
• Date Manufacturer Received: 10/23/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/30/2013
• 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