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 Date 02/03/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4).The actual device was not returned, however, 39 unused samples from the reported lot were returned to the manufacturing facility.Therefore, the investigation was based upon evaluation of the user facility information, the 39 returned unused samples, and retention samples from the reported product code/lot number combination.A visual and sensory inspection of the 39 returned unused samples revealed no defects.A visual and sensory inspection of the retention samples revealed no defects.Functional testing was conducted on the 39 unused samples and retention samples and could not reproduce the reported failure.A review of the manufacturing records was conducted with no relevant findings.Prior to shipment, qc conducts outgoing visual, functional, and sensory inspection and all samples for the reported complaint lot passed.See mdr no.3003902955-2017-00005 for the first event reported for a different patient.The investigation results verified that the 39 unused samples and the retention samples were the normal product.There is no evidence that this event was related to a device defect or malfunction and the exact cause for the reported event cannot be definitively 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 appropriate tracking, trending and follow-up.

Event Description

It was reported from the mckesson representative that "the safety cap does not snap into place over the needle, it drifts away from the needle.We've had two nurses stuck with safety hypodermic needles in the last month." additional information was provided on 2/17/17 by the rn: "nurse delivered injection without incident, and closed the safety needle, against the table, and thought she heard it click.Nurse was stuck when attempting to remove used safety needle from used meds vial, which the rn stated is common practice for nursing staff to do post immunization, for meds lot documentation.The rn stated she is going to suggest the staff no longer practice the removal of needle from vial, in case that was related to the needle being exposed.Per facility protocol the nurse received post exposure blood testing, and immunization, then returned to work.On 2/22/17 the user facility reported that the nurse who incurred needle stick with used needle during attempted removal of safety needle from vial.Nurse returned to work after protocol testing/treatment completion.Post exposure testing was negative for infectious disease.

• 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: 6406198
• MDR Text Key: 69998460
• Report Number: 3003902955-2017-00006
• 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: company representative,distri
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2021
• Device Catalogue Number: 102-N251S
• Device Lot Number: 160505B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/15/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/05/2016
• 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
• Treatment: PREFILLED MEDS VIALS : FLU SHOTS, ETC.; PREFILLED MEDS VIALS : FLU SHOTS, ETC.
• Patient Outcome(s): Required Intervention