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 02/15/2018

Event Type  malfunction  

Manufacturer Narrative

The lot number is unknown for this complaint.The following are potential lot numbers and expiration dates for the reported product code: (sg3+2051) (1) 150102c - 12/31/2019 (2) 160408c - 03/31/2021 (3) 160603c - 05/31/2021 and (4) 141230c - 11/30/2019.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 potential involved product/lot number combination.Retention samples revealed no defects.We have in-process inspection for visual, sensory test and functional test to assure quality performance of assembled sg3 needle.Prior shipment, qc conducts outgoing inspection to assure lots are in good quality.Without the return of the actual device the exact cause cannot be definitely determined based on the available information.(b)(4).

Event Description

The user facility reported that after a pharmacist was giving medication to a patient the pharmacist incurred a needle stick.The needle stick occurred on the top third of the pharmacists left middle finger.This resulted in a couple drops of blood.It was reported that once the needle guard flipped, the needle guard did not stay in place and did not cover the needle.Pharmacist reported that the safety needle guard did not have what it needed inside of it to hold it in place.Additional information received on (b)(6) 2018: it was reported that the needle was provide in the risperdal consta kit and that the needle was the longer glute needle.Additional information received on (b)(6) 2018: it was reported that the patient did receive the intended does of risperdal.The pharmacist who was stuck is fine and no additional medical intervention was required.

• 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: 7344734
• MDR Text Key: 103155398
• Report Number: 3003902955-2018-00006
• Device Sequence Number: 1
• Product Code: FMI
• 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,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/16/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• 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+2051
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/21/2018
• 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