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

Catalog Number	TN-3404
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	04/20/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Udi number for this product code is not required.The actual device was returned to the manufacturing facility for evaluation.Visual inspection confirmed the needle was broken near where the hub and needle were bonded.Deformation of the needle and fractured section were noted.Scrap marks on the adhesive was also noted.The needle tip was bent and there was some damage at the cross-section of the needle.Fracture tolerance testing was conducted on the reported needle type and confirmed to meet manufacturing specification.A review of the manufacturing inspection record of the reported lot was conducted with no relevant findings.A review of the complaint files there has been no similar events reported.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 labeling does address the potential for such an event in the instructions-for-use (ifu) with statements such as the following: "puncture the skin vertically, and maintain the position during delivering the drug." and "do not change the angle of pen after penetrating the skin in order to avoid breaking of the needle.In case the needle breaks off and remains in the body, please contact a doctor immediately." 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 customer reported a needle breakage during use of the device.Follow up communication with the pharmacy that the product was purchased from reported the following information: according to the patient who handled the product when the needle snapped, bleeding was shortly observed from the patient's skin; normal handling practice was followed; the fragment was successfully removed by the patient; the reported incident happened at the patient's home, the concerned product was purchased from the pharmacy listed in the user facility section; the patient was able to treat oneself; the patient has been a long time user of nanopass and has been the first incident ever experienced; and the current condition of the patient was reported to be fine.

• Brand Name: PEN INJECTOR NEEDLE
• Common Device Name: INJECTOR PEN
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 583; JA 409-3583
• MDR Report Key: 6577281
• Report Number: 9681835-2017-00012
• Device Sequence Number: 16161826
• 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,consum
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date (Section B): 05/18/2017

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: 11/30/2021
• Device Catalogue Number: TN-3404
• Device Lot Number: 161217H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/24/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/20/2017
• Initial Report FDA Received Date: 05/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INSULIN; MIRIOPEN; INSULIN; MIRIOPEN