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

Catalog Number	TN-3404
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	03/08/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Implanted date: device was not implanted.Explanted date: device was not explanted.Device manufacture date - requested but unknown.The actual device not returned to the manufacturing facility for evaluation.Therefore, no evaluation was completed.The record was traced back five (5) years and found no irregular findings in automated cannula inspection device.Furthermore, random pick up inspections were performed to check the needle tip and length on the side where the cartridge is attached.No irregular finding was witnessed as a result.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 touch the needle directly", "be careful about needle stick injury", "hold the pen-injector firmly while you screw the needle counterclockwise and remove it from the pen-injector." and "dispose of safely after single use to avoid risk of injection." 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 a patient with osteoporosis visited the hospital and injected forteo subcutaneous injection by oneself.When care worker attempted to remove the used needle from pen device upon completion of administration, the care worker accidentally touched the needle on device site and simultaneously punctured hand.Proper cure was taken based on provision exclusively stipulated for needle-puncture.Subcutaneous injection was successfully performed on patient.No potential health hazard for the care worker has so far been reported to the hospital.

• 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: 7396505
• Report Number: 9681835-2018-00011
• Device Sequence Number: 83955
• 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): 04/04/2018

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?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/08/2018
• Initial Report FDA Received Date: 04/04/2018
• 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: TERIPARATIDE