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

Catalog Number 3SG2-3013

Device Problems Break (1069); Use of Device Problem (1670)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/16/2014

Event Type  malfunction  

Event Description

The user facility reported a nurse was using a sg2 needle for sub- q injection with bd 1cc syringe incurred a needle stick.Follow up communication with the use facility reported the following: (1) the nurse was able to successfully activate the safety device on a hard surface, and heard the audible click; (2) when the nurse picked up the device, post activation; she felt a "pinch"; (3) the nurse realized she was stick by the needle; (4) the needle had broken away from the hub; (4) procedure outcome was successful; and (5) there was no impact to the patient, and medical intervention was not required for the nurse or patient.

Manufacturer Narrative

(b)(4).Results- is based upon the evaluation of the user facility information & the returned sample; the retention and current lot samples.Conclusions - is based upon evaluation of the user facility information & the returned sample; the retention and current lot samples.The involved device was returned to the manufacturing facility for evaluated.Visual inspection confirmed the hub and needle was broken apart.Magnification of the actual sample confirmed the remaining cannula on the hub was slightly bended, with rough edges around cannula top portion.The portion of the cannula left inside the hub, epoxy portion appears to be deformed, with rough edges and tilted.Evaluation of the retention samples and current lot samples showed no anomalies.A review of the lot history records indicated that there were no production related problems.There is no evidence that this event was related to a device defect or malfunction.Although the cause for the reported break cannot be definitively determined based upon the available information, the appearance of the involved sample is most consistent with being exposed to excessive force.Device labeling does address the potential for such an event in the instructions-for-use (ifu) by statements such as, (1) therefore, we recommend activating the safety sheath with a firm and quick motion on a flat surface and sheath must be positioned approximately 45 degrees.(2) also, please be reminded to visually confirm that the needle is fully engaged under the lock and keep the finger or thumb behind the tab at all times to prevent a needle stick.All available information has been placed on file in quality assurance for appropriate tracking, trending and follow-up.(b)(4).

• Brand Name: SURGUARD2 SAFETY NEEDLE
• Type of Device: SAFETY SYRINGE
• 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: 4423353
• MDR Text Key: 5168330
• Report Number: 3003902955-2014-00030
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/17/2014,01/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/15/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Catalogue Number: 3SG2-3013
• Device Lot Number: 130701B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2015
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/16/2014
• Device Age: 17 MO
• Event Location: Hospital
• Date Report to Manufacturer: 12/17/2014
• Date Manufacturer Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2013
• 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
• Treatment: B-D 1CC SYRINGE. "LOVENOX"