MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY NEEDLE (MCKESSON); SYRINGE, ANTISTICK

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

Udi - unavailable due to the lot number being unknown.The actual device was not returned to the manufacturer for evaluation.The lot number is unknown for this complaint.Since lot number is unknown, our investigation is limited.Prior to shipment, qc conducts outgoing visual inspection to assure all lots pass.Since the product lot number is unknown, our investigation is limited and prevented a meaningful review of production or complaint records.There is no evidence that this event was related to a device defect or malfunction.Without the return of the actual device the exact cause cannot be definitely determined.(b)(4).All available information has been placed on file in quality assurance for appropriate tracking, trending and follow up.

Event Description

It was report through a distributor that a customer had an issue with the safety engaging and incurred a needle stick with the involved device.The customer stated "i activated the safety device (the green part) as i was putting it properly into the sharps container, the device popped open and hit the side of the container which sent the needle into my thumb.I honestly didn't do anything wrong in practice or wasn't moving too fast or anything but the safety device on this needle is horrible.I tested it this morning and another person did too.In order to truly activate it you had to press very hard and have you hand on the actual shield next to the needle which is just as dangerous." the facility reported incurred a needle stick to the thumb.The safety needle came out of the sheath when knocked inadvertently during disposal, resulting in needle stick to thumb.Additional information was received from the distributor on 10/13/2017.It was user error.The customer has evaluated and decided this was not a product issue and that the safety needle operated as it should have, but the user had not fully engaged the safety.

• Brand Name: TERUMO SURGUARD2 SAFETY NEEDLE (MCKESSON)
• 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: 7002917
• MDR Text Key: 92167939
• Report Number: 3003902955-2017-00032
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/06/2017

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 Model Number: N/A
• Device Catalogue Number: 102-N251S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/09/2017
• Initial Date FDA Received: 11/06/2017
• 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