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

Model Number	N/A
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	11/20/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The actual device has not been returned to the manufacturing facility for evaluation.Therefore, the investigation was based upon evaluation of user facility information, and evaluation of retention sample.Based on the results of our investigation, the cause of the complaint could not be identified since condition of the actual sample was not confirmed.Retention samples were confirmed free from defects such as tooth flash, missing tooth, damaged collar ear, sheath collar fitting, and over or under insertion of collar to hub.Related functional testing such as sheath activation and deactivation were all passed.Molding condition of the components critical to the safety activation is checked to assure that no defects will be encountered that will lead to sheath activation problem.In addition, no difficulty was encountered during the simulation of retention samples.An audible click was heard indicating successful safety activation.The cannula is securely locked and no irregularity and bending or tilting of cannula was noted.We have in-process inspection for visual, sensory test and functional test to assure quality performance of assembled sg2 needle.Prior shipment, qc conducts outgoing inspection to assure lots are in good quality.All samples passed.The investigation is currently ongoing.A follow up report will be submitted once the investigation is complete.For this reason, evaluation code 11 has been referenced in the conclusions section.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.
Event or Problem Description
The user facility reported that the safety mechanism is faulty and a needle stick occurred as a result.The safety mechanism did not catch.Additional information received on (b)(6) 2018: during the patient admission, the client began vomiting on the floor and around the toilet.An im phenergan was ordered.The patient was laying on the floor, inebriated, retching and crying.A phenergan injection was administered, with a mckesson safety syringe, into the patients left deltoid.The safety mechanism was moved into place, and felt like it was clicked into place.A bandage was placed on the patient's injection site, and comfort was provided to the client while he was lying on the floor.When the bandage, alcohol wrappers, and the needle was picked up to dispose of, the safety cap moved back off of, and exposed the needle, inadvertently sticking the nurse in the left thumb.The actual patient was not impacted.The procedure of the injection was completed as intended.The nurse involved got blood work done as per policy.She was offered the option of prophylactics and declined due to the history of the patient being non-high risk.Patients' blood work was ordered to rule out any infectious disease.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide the device returned date and to provide the completed investigation results.Twenty pieces of unused same lot samples were returned to the manufacturing facility for evaluation.No defects were found that may result to the complaint.Based on the results of our investigation, the cause of the complaint could not be identified.Received unused same lot samples were visually inspected and no defects were found that may result in activation failure.Moreover, samples undergone relative testing such as sheath activation and deactivation.All samples are within specification.

• Brand Name: MCKESSON MEDI-PAK PERFORMANCE SYRINGE WITH SAFETY NEEDLE
• Common Device Name: SYRINGE, ANTISTICK
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 8199348
• Report Number: 3003902955-2018-00048
• Device Sequence Number: 19320824
• Product Code: MEG
• UDI-Device Identifier: 30612479179067
• UDI-Public: 30612479179067
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051865
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2022
• Device Model Number: N/A
• Device Catalogue Number: 102-SN3C231S
• Device Lot Number: 171020A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/27/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/03/2018
• Supplement Date Received by Manufacturer: 12/27/2018
• Initial Report FDA Received Date: 12/27/2018
• Supplement Report FDA Received Date: 01/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 47 YR