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

Model Number N/A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 11/18/2022

Event Type  malfunction  

Event Description

The user facility reported that a presence of a 17mm metal piece extracted from a patient's injection site.The patient was given intramuscular injection of decapeptyl 11.25mgs and prescribed two (2) days later found injection site painful and felt a small piece of metal protruding out of injection site.The event occurred post-treatment.The nurse has confirmed on (b)(6) 2022, that there were no issues at the time of the injection.The patient removed the needle when he felt a small piece of metal protruding out of the injection site.Injection site healed with no adverse effect.The patient was adamant that the needle came out of the injection site.

Manufacturer Narrative

Lot number: potential lots: 210220 & 210222.Expiration date: potential dates: : not applicable.Operator of device: unknown.Implanted date: device was not implanted.Explanted date: device was not explanted.Occupation: quality manager.Device manufacture date: potential dates: 2021-feb-20 and 2021-feb-22.The actual sample was not available.Instead, a reference photo of the metal piece extracted from the patient was provided by te.The foreign material was metallic, solid, and has a diameter of 266-268 m.The foreign material is composed of copper-free tinned iron based on the analysis conducted by te.The retention samples were visually inspected and confirmed free from any foreign material.No simulation and evaluation were conducted.Based on the results of our investigation, the root cause of the complaint could not be identified to be related to our production or process.The foreign material that was left in the patient was identified to be a solid metallic rod.It was composed of copper-free tinned iron based on te analysis.This confirms that the issue is not related to a cannula breakage of the sg needle.The cannula undergone luminance inspection at the cannula inspection process where each cannula lumen is visible to the inspector.Based on records, there has been no reported foreign material found inside the cannula.Moreover, if there is solid metallic rod inside the cannula it will dropped during the silicone dipping and if the metallic rod clogged the cannula lumen the air will not pass through during the needle assembly clogged inspection system this will be automatically rejected.Our investigation reveals that there have been no tests conducted from the incoming inspection until the release of the products that require any tools to be inserted inside the needle.We confirm that the foreign material did not come from our process.All related records, such as the incoming inspection and the result of the 100% inspection at cannula inspection, conform.There has been no non-conformity issue during the production of the reported lot from the needle assembly process until surguard process.Terumo medical products (tmp) (importer) registration no.(b)(4) is submitting this report on behalf of terumo (philippines) corporation (manufacturer) registration no.(b)(4).

• 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, ; RP
• Manufacturer (Section G): TERUMO PHILIPPINES CORPORATION; 124 east main avenue; laguna technopark; binan, laguna,, ; RP
• Manufacturer Contact: gina digioia ; 265 davidson ave; suite 320; somerset, NJ 08873 ; 6402040886
• MDR Report Key: 16021078
• MDR Text Key: 308261033
• Report Number: 3003902955-2022-00066
• Device Sequence Number: 1
• Product Code: MEG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K051865
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: N/A
• Device Catalogue Number: SG80B2038
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/29/2022
• 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
• Treatment: DECAPEPTYL.
• Patient Age: 83 YR
• Patient Sex: Male