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 11/09/2017

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 were 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 investigation revealed that the retention samples were the normal product.Without the return of the actual device the exact cause cannot be definitely determined.The user facility reported a similar event from the same product code/lot number combination.See mdr 3003902955-2017-00049 for the first event that occurred.(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 very next day, the clean needle stick occurred when she was preparing to give an injection, and touched the needle tip on unsterile surface accidentally, so she activated the needle for disposal against a hard surface.It was reported that she was sure the needle was activated, but "the tip was still sticking out", so she was stuck.There was no further impact to the office assistant, and no impact to the patient that was being treated.

Manufacturer Narrative

This report is being submitted as follow up no.1 to provide the device return date & the completed investigation.The actual device was returned for evaluation.Two 25 gauge safety needles were received.The safety needles were already activated upon receipt.Sample one was noted to be activated on the collar part however not fully engaged on the sheath tooth lock.This was due to bent needle or tilted cannula of the sample.Furthermore, no other abnormalities observed on the received samples.Verification of the received actual samples showed 2 pieces activated safety needles, wherein one of the samples was observed locked on the collar part only however not fully engage on the sheath tooth.This condition was due to bent needle observed on the sample.Based on the simulations conducted, activation of the sg3 needles following the ifu will not cause bending of the needles.There is no indication that this event was related to a device defect or malfunction and the exact cause cannot be definitively determined.

• 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: 7099916
• MDR Text Key: 95078479
• Report Number: 3003902955-2017-00050
• 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,Followup
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/23/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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