MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD3 HYPODERMIC NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number N/A

Device Problem Difficult to Open or Close (2921)

Patient Problem Needle Stick/Puncture (2462)

Event Date 11/08/2017

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.Functional testing was conducted.Retention samples were subjected to manual sheath activation by simulation following and using the three methods of activation stated in the instruction for use.Manual sheath activation by simulation was conducted successfully on all samples without difficulty.No slipping of products was observed and all were easily closed.The safety sheath on all samples were observed fully engaged.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 3003902955-2017-00050 for the second event that occurred.The investigation revealed that the retention samples were 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 that an assistant at the office incurred a needle stick from a used needle.It was reported that she was wearing gloves and that she has used these types of needles before.That same night, (b)(6) 2017 she went for blood work.The needle was used prior for a (b)(6) shot to a female patient.It was reported that the device did not securely lock when trying to close them.When they are pressed down, it doesn't engage, it just sticks up.The patient that was being treated received (b)(6) shot as intended.The assistant that incurred the needle stick did not require further treatment.It was reported this has happened a second time but with a clean needle.Additional information was received on 11/21/2017.The assistant that incurred the needle stick was negative for infectious disease.The assistant reported the following.An injection was performed against a flat surface and confirmed it was fully activated, but when she went to dispose of the needle the "tip was still exposed, so she got stuck".It was reported that the needle remained activated, however the tip was still exposed.She went for blood work that evening per facility protocol, and returned to work.The patient was negative for infectious disease, and was not impacted.She is fine, and no further treatment or impact from needle stick.

• Brand Name: TERUMO SURGUARD3 HYPODERMIC NEEDLE
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• 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: 7099958
• MDR Text Key: 95078585
• Report Number: 3003902955-2017-00049
• Device Sequence Number: 1
• Product Code: FMI
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Model Number: N/A
• Device Catalogue Number: SG3-2525
• Device Lot Number: 170407D
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/07/2017
• 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: 26 YR