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

Model Number N/A

Device Problems Use of Device Problem (1670); Fail-Safe Problem (2936); Material Protrusion/Extrusion (2979)

Patient Problem Needle Stick/Puncture (2462)

Event Date 08/25/2017

Event Type  malfunction  

Manufacturer Narrative

Udi - not yet covered by the udi implementation cut-off.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.Functional testing was conducted: sheath activation and sheath deactivation force were evaluated on the retention samples and confirmed all samples met manufacturer specifications.Retention samples were used in the simulation through manual sheath activation.The syringe was securely tightened into needle by pushing and turning the syringe clockwise.The safety sheath was moved away from the needle and towards the syringe barrel to the angle, and the needle cap was removed in a straight manner.The safety mechanism was activated by surface activation.The safety sheath was successfully activated.A review of the lot history files were conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual, sensory and functional inspections and all samples for the complaint lot passed.The investigation revealed that the retention samples were the normal product.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual sample the exact cause cannot be determined.Event problem and evaluation codes are unable to be selected at this time, esubmitter support has been notified.(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 that the ma was in required with the needle stick.The incident occurred after activating the safety device.The patient that was being treated asked for something so the ma secured needle down, and when the ma went to pick it up the ma grabbed it by the sheath and the needle was poking out of the sheath and stuck her.It was reported that they both felt that all the 25g needles are more flimsy allowing them to poke out of the sheath.It was reported that the sheath can also be deactivated from the needle if you try to remove it.It was reported that the patient being treated was not affected.It was reported that the procedure outcome was not affected.

Manufacturer Narrative

This report is being submitted as follow up no.2 to provide additional information.It was initially reported there was no information about the device being available for evaluation, however it has been confirmed that the device was not returned.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the codes and to provide the actual device evaluation and completed investigation.The codes were unable to be selected when the initial report was submitted, the codes are now available and have been selected.

• 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: 6893087
• MDR Text Key: 88063971
• Report Number: 3003902955-2017-00019
• 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,Followup,Followup
• Report Date: 09/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: SG3-2525
• Device Lot Number: 160804D
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2017
• 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