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 10/31/2017

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.A review of the lot history files was conducted with no findings.Prior to shipment, qc conducts outgoing visual inspection, sensory inspection and functional testing all samples for the complaint lot passed.The user facility reported a similar event from the same product code/lot number combination.See mdr's 3003902955-2017-00042 and 3003902955-2017-00040.The investigation results verified that the retention sample was the normal product.Without the return of the actual device, the exact cause cannot be definitely determined.(b)(4).

Event Description

The user facility reported needle stick injury.The safety needle was used as intended but either the needle pushed through the side of the shield or the needle was just not properly secured in the safety portion causing the tip to push forward and be exposed outside the housing.It was reported that there was no impact on actual patient, who received injection as intended.Additional information was received on 11/7/2017: the hcp activating safety on sg3 post procedure, and was stuck when needle was not secured in as thought.The hcp activated against hard surface (table).Facility protocol followed for post exposure testing, which was negative, and hcp returned to work with no harm.

• 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: 7068162
• MDR Text Key: 93869520
• Report Number: 3003902955-2017-00041
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 34806017508204
• UDI-Public: 34806017508204
• 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: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3-2525
• Device Lot Number: 170204D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/02/2017
• Initial Date FDA Received: 11/29/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/04/2017
• 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
• Patient Age: 47 YR
• Patient Weight: 71