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

Catalog Number TN-3404

Device Problems Material Puncture/Hole (1504); Use of Device Problem (1670)

Patient Problem Needle Stick/Puncture (2462)

Event Date 09/19/2018

Event Type  malfunction  

Manufacturer Narrative

Pt info: requested, not provided.Lot #, 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 (b)(6).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 revealed that the sharp needle was being protruded through the inner needle cap as initially reported.Even though the protruded needles seen on the cap was believed to be two pieces, it was identified to be only one and what it appeared to be another needle, was a black adhesion on the cap.The protruded needle seen on the inner needle cap was pointing diagonally upward.Meantime, assembly process of the outer needle case is normally placed onto the inner needle cap.To verify the issue, one piece of a retention sample was used for simulation testing.During this simulation test, the tip of the needle was intentionally penetrated through the inner needle cap the same way as the actual sample, then the outer needle cap was placed.When the cap was removed afterward the tip was confirmed to be deformed.The actual piece was examined through the same simulation test as the retention sample.Likewise, the protruded needle was once covered by the outer needle cap as normal and was later removed.The needle was confirmed to be deformed and the tip was pointing downward.As a result of aforementioned series of examinations, both tests demonstrated that the reported issue was not likely to encounter during our assembly process, because protruded needle through the inner needle cap can easily be deformed as the tip points downwards while being covered and pressed on the needle.The record was traced back up to 5 years and reviewed in which duration is equivalent to expiration of the product.No irregular finding in relation to attribute reported event caused by mechanical trouble, or mechanical malfunction on automated inspection device, was observed.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: "after the administration, pull out the needle from the injection site.Only in case of self-injection, carefully replace the outer needle cap straight." (b)(4).

Event Description

The user facility reported that two needles were being protruded through the inner needle cap, causing the user to suffer a needle stick injury.Additional information was received on (b)(6) 2018: during preparation, the patient sensed pain on the fingers.When confirmed two needles were being protruded through inner the needle cap.It was reported that the patient is fully recovered.Additional information was received on (b)(6) 2018: the patient was examined at the medical institution and reported the incident one on (b)(6) 2018.Two pieces of sharp needles were being protruded through the inner needle cap.(they protruded the cap as v-shaped).

• Brand Name: PEN INJECTOR NEEDLE
• Type of Device: PEN INJECTOR NEEDLE
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; reg. no. 9681835; 1727-1, tsuiji-arai, showa-cho; nakakoma-gun, yamanashi 409-3 853; JA 409-3853
• Manufacturer Contact: mark vornheder ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 7980960
• MDR Text Key: 125112170
• Report Number: 9681835-2018-00032
• Device Sequence Number: 1
• Product Code: NSC
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K140516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 10/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: TN-3404
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/27/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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