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

Catalog Number SG2-01T2516

Device Problem Use of Device Problem (1670)

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

Event Date 12/15/2014

Event Type  malfunction  

Event Description

The user facility reported that the protective cap was removable and would not snap into place and pops out making the needle exposed.Follow up communication with the user facility confirmed: (1) several incidences of needle stick injuries; (2) there was no know medical intervention or know exposure to infection; and (3) it was stated that no major incidents with any dangerous material.

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.Device not returned.

Manufacturer Narrative

As stated, this report is being submitted for follow-up # 1 for mfg.Report # 3003902955-2014-00029 to provide representative sample evaluation results.The involved device was not returned to the manufacturing facility for evaluation, and the lot number was not provided by the user facility.Therefore, the investigation was based upon user facility information and representative samples.Visual inspection of the collar, safety sheath and the sheath tooth were free from molding related defects and damages or deformation.The safety sheath was properly attached on the assembled needle and the collar was fully seated on the hub.Representative samples were evaluated through a sensory inspection.The safety needle was attached into the syringe.The sheath lugs were firmly attached to the collar ears.The sheath was moved to a 135 degree position and the needle was pointed downward.The sheath remained in the applied position.No movement on the sheath was observed.Dimensions of the sheath tooth was performed on the retention samples.The tooth length, tooth base thickness and tooth tip thickness all met manufacturing specifications.The sheath activation and sheath deactivation force was evaluated on the representative samples, using the tensile / compression equipment which met manufacturing specifications.A comment was made by the user facility that several incidences of needle stick injuries had occurred.However, those events were not reported to the manufacturer and no additional information was available including event dates, product codes, patient information or any specific event descriptions.Therefore, because it is not possible to conduct meaningful investigations or obtain sufficient information about the individual events, we are including this anecdotal information within this follow-up report for reference purposes.The production lot number was not provided by the user facility, which prevented review of applicable production or complaint records.Although the exact cause cannot be determined, there is no evidence that this event was related to a device defect or malfunction.Device labeling does address the potential for such an event in the instructions-for-use (ifu) by statements such as, 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.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 currently available information has been placed on file by the qa at the manufacturing facility for appropriate tracking, trending and follow-up.(b)(4).Device not returned.

Event Description

This report is being submitted for follow-up # 1 mfg.Report # 3003902955-2014-00029 to provide representative sample evaluation results.

• Brand Name: SURGUARD2 SAFETY SYRINGE WITH 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: 4413890
• MDR Text Key: 5168152
• Report Number: 3003902955-2014-00029
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2014,01/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/13/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: SG2-01T2516
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 12/15/2014
• Event Location: Hospital
• Date Report to Manufacturer: 12/15/2014
• Date Manufacturer Received: 12/22/2014
• Was Device Evaluated by Manufacturer?: No
• 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