MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO SURGUARD2 SAFETY HYPODERMIC NEEDLE; SYRINGE, ANTISTICK

Model Number N/A

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 10/14/2017

Event Type  malfunction  

Manufacturer Narrative

Ethnicity - requested but not provided.Udi - unknown due to the lot number being unknown.Lot number: unavailable.Expiration date - unknown due to the lot number being unknown.Explanted date: device was not implanted.Device manufacture date - unknown due to unknown lot number.The actual device was not returned for evaluation and the product code and lot are unknown.No evaluation could be conducted due to the device not being returned.There is no evidence that this event was related to a device defect or malfunction.With no device return the exact cause of the reported event cannot be definitively determined based on the available information.The production lot number was not provided by the user facility, which prevented a meaningful review of the device history record and complaint files.Prior to shipment, qc conducts outgoing visual inspection and all samples for the complaint lot passed.The user facility reported similar events from the same product code/lot number combination.See mdrs 3003902955-2017-00043, 3003902955-2017-00044, 3003902955-2017-00045, and 3003902955-2017-00046.(b)(4).

Event Description

The user facility reported a needle stick.It was reported that no needles were noted to be bent prior to activation of safety device.Hcp affected on incident.The patient was not affected.

• Brand Name: TERUMO SURGUARD2 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: 7137446
• MDR Text Key: 96041014
• Report Number: 3003902955-2017-00054
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/21/2017

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-N231S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/21/2017
• Initial Date FDA Received: 12/21/2017
• 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
• Patient Age: 28 YR
• Patient Weight: 57