MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION MCKESSON MEDI-PAK PERFORMANCE SAFETY NEEDLE; SYRINGE, ANTISTICK

Catalog Number 102-N251S

Device Problem Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Type  malfunction  

Manufacturer Narrative

Udi - not applicable since the lot number is unknown.The actual device was not returned to the manufacturer for evaluation and the lot number is unknown.Since product lot number is unknown, our investigation is limited and a review of production or complaint records was not possible.Visual, sensory and functional testing is conducted to assure all assembled sg2 needles meet manufacturer specifications.Prior shipment, qc conducts outgoing inspections and testing to assure all lots pass.Based on the limited product information provided, no probable root cause could be determined.Terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.3003902955.Exemption number e2015017.All available information has been placed on file in quality assurance for tracking, trending, and follow up.Device not returned to manufacturer.

Event Description

It was reported from (b)(4) that "this customer orders a ton of this product from us and they haven't had any issues, but in the last few months they have had six needle sticks with this product".See mdrs 3003902955-2016-00041, 3003902955-2016-00042, 3003902955-2016-00043, 3003902955-2016-00044 & 3003902955-2016-00046 for the other five reported events.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SAFETY 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: jennifer suh ; reg. no. 2243441; 2101 cottontail ln.; somerset 08873 ; 8002837866
• MDR Report Key: 6150898
• MDR Text Key: 61616455
• Report Number: 3003902955-2016-00045
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/07/2016

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 Catalogue Number: 102-N251S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/07/2016
• 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