MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU PEN INJECTOR NEEDLE

Catalog Number	TN-3404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	03/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient identifier - requested, not provided.Age and date of birth - requested, not provided.Sex - requested, not provided.Weight - requested, not provided.Ethnicity -requested, not provided.Race - requested, not provided.Lot number - requested but unknown.Expiration date - requested but unknown due to lot number being unknown.Udi - the corresponding lot is not subjected for udi.Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - requested but unknown due to lot number being unknown.The actual device was returned to the manufacturing facility for evaluation.Visual inspection was conducted on the actual sample, when closely verified the needle was completely snapped off from its hub and some scratches were observed on adhesive glue on hub.There were no major scratches or rust that could degrade the overall strength of the needle.Our observations of the damage showed the following properties: the needle-hub and snapped portion were both deformed and that the adhesive glue was scraped.As a result, the needle was first presumed to be bent at its hub, and was later snapped off.The threads in the needle-hub were also observed.The needle-hub was scratched with a stressed mark, which indicates that the inner needle-hub may have been connected with excessive force.The ribs on the needle-hub were also observed to be scratched with a stressed mark in which excessive force may have been applied while being connected.Every criterion was checked through methods and complied "fracture tolerance" regulated by iso standard and every category has fulfilled the requirement.Because of our verification, the concerned needle type was confirmed to fulfill above requirement.The record was traced back up to 5 years and reviewed, and found no irregular finding in relation to defective needle length caused by mechanical trouble, or malfunctions of the inspection device.Furthermore, random inspection of the product is periodically performed to closely check physical condition.No irregularities to attribute the reported event, including needle damage, scratch or bend were noted in the record.There is no evidence that this event was related to a device defect or malfunction.The exact cause of the reported event cannot be definitively determined based on the available information.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not change the angle of the pen after penetrating the skin, in order to avoid breaking of the needle" and "in case the needle broke off and remains in the body, please contact immediately a doctor." terumo medical products (tmp) (importer) registration no.2243441 is submitting this report on behalf of kofu factory of terumo corporation (manufacturer) registration no.9681835.Exemption number e2015026.
Event or Problem Description
The user facility reported that the patient is a person who visits chemotherapy, relies on long-lasting levemir® each morning, and handles it roughly.According to the patient, the outer needle cap was once placed on used needle to screw and remove it from pen injector, it was however unable to do so.The patient had then pulled the tighten cap forcibly and removed it off from the pen injector, and later placed a pen injector cap instead.When the nurse obtained the pen injector from the patient, the needle had already been damaged and missing from its hub.The nurse assumed that the needle might have been damage while it was being withdrawn tilted may have first caused to become fragile and it was eventually snapped as the patient removed the outer needle cap forcibly.It is unreported that whether the patient was able to successfully dose the insulin injection oneself.The nurse closely examined injected area of the patient after confirming the fact that the needle was damaged.It is undeniable that if needle fragment still remained in the patient, due to the event was occurred immediately after skin penetration.

• Brand Name: PEN INJECTOR NEEDLE
• Common Device Name: PEN INJECTOR NEEDLE
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• MDR Report Key: 7468095
• Report Number: 9681835-2018-00020
• Device Sequence Number: 10795041
• Product Code: NSC
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K140516
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/27/2018

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 Catalogue Number: TN-3404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2018
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2018
• Initial Report FDA Received Date: 04/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1