MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION SURGUARD3 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 07/24/2017

Event Type  malfunction  

Manufacturer Narrative

The actual device was not returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, and retention samples of the involved product/lot number combination.Visual inspection revealed no defects.Sheath activation test verified the retention samples passes specification.Manual activation was performed and all samples were successfully activated without difficulty.A review of the lot history files was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspections, and functional testing and all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr 3003902955-2017-00029.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause cannot be definitely determined.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.

Event Description

The user facility reported needle sticks.The following information was provided by the user facility: our company has started using the terumo surguard 3 needles and the staff needs some education on the use of these needles especially our pediatrics department; they have had some needle sticks since using this product; and there were no other devices or equipment being used with the reported product.Additional information was received on (b)(6) 2017.The clinicians had needle sticks with sg3-2516.Both needle stick occurrences were from thumb activations and both did not fully engage/activate all the way, and in both instances the needle was sticking out of the sheath.When the clinicians grabbed the safety needle to discard it they held it up by the sheath/needle and got stuck by the needle.The patients were not affected, and there are not any health concerns for the clinicians.

• Brand Name: SURGUARD3 SAFETY HYPODERMIC NEEDLE
• Type of Device: SYRINGE, ANTISTICK
• 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,, reg. no. 3003902955 ; RP
• Manufacturer Contact: terry callahan ; reg. no. 2243441; 2101 cottontail ln.; somerset, NJ 08873 ; 8002837866
• MDR Report Key: 6812831
• MDR Text Key: 83534275
• Report Number: 3003902955-2017-00030
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K122249
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2021
• Device Model Number: N/A
• Device Catalogue Number: SG3-2516
• Device Lot Number: 160628D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/28/2016
• 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