MAUDE Adverse Event Report: TERUMO PHILIPPINES CORPORATION TERUMO NEEDLE; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bacterial Infection (1735); Swelling (2091)
Date of Event	02/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: doctor of veterinary medicine.The actual device has not been returned for evaluation.Based on the result of the investigation, the root cause of the complaint could not be identified.Since actual defective sample was not returned for investigation, we cannot provide detailed information of its actual condition.Retention samples were visually inspected and confirmed free form any contributing defects that would lead to the complaint.Each lot we produce undergoes needle penetration and bacterial endotoxin to assure that our finished products are safe for use and would not cause harm to patient.Based on the records, results are all passed and in accordance to the specification.In addition, we have physicochemical test that is conducted monthly to check the traces of metals and acidity/alkalinity.Results were also passed.Our products are confirmed biocompatible in accordance with iso (b)(4).All finished products are sterilized through electron beam sterilization process and it is also pyrogen-free and does not contain any substance that may cause fever when injected into the blood stream.Furthermore, qc conducts outgoing visual, sensory, and functional inspection to check the condition of the products prior shipping.This issue has been escalated to capa (capa#: (b)(4)) to further confirm our investigation and to verify the effectiveness of the implemented corrective action.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 a patient received an injection and might have gotten an infection.Patient is in good condition post treatment for injection site infection.Patient's original symptoms were resolved, as well as the swelling at the injection site.Additional information received on (b)(6) 2019: the (b)(6), neutered, male pit-bull, was presented with vomiting and diarrhea on (b)(6) 2019.The dog was treated with sub-q fluids for symptoms and with injections of metronidazole and was released.On (b)(6) 2019 the facility was contacted to that the injection site area was swollen and hot.The animal was returned to facility for treatment including culture of injection site and pain medication.No antibiotics were given as he was already being treated with metronidazole.The area culture tested positive for two types of bacterial organisms.The patient was released the same day.The area was resolved after several days as reported in the follow up appointment.
Additional Manufacturer Narrative
This report is being submitted as follow up no.1 to provide a correction to the d4 section.In the initial report it was reported that catalog # was nn-1825r; however the correct catalog # is nn1825r.

• Brand Name: TERUMO NEEDLE
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna ; RP
• MDR Report Key: 8478230
• Report Number: 3003902955-2019-00018
• Device Sequence Number: 11188703
• Product Code: FMI
• UDI-Device Identifier: 34806017511839
• UDI-Public: 34806017511839
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K121607
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/30/2023
• Device Model Number: N/A
• Device Catalogue Number: NN1825R
• Device Lot Number: 180714C
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/06/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: RES 82212
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: LACTATED RINGERS; SUB-Q FLUIDS AND METRONIDAZOLE
• Patient Age: 1 YR