MAUDE Adverse Event Report: TERUMO CORPORATION - KOFU TERUMO DENTAL NEEDLE; NEEDLE, DENTAL

Catalog Number DN-3021KL

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/11/2018

Event Type  malfunction  

Manufacturer Narrative

Expiration date - august 2021.Udi - the corresponding lot is not subjected for udi.Implanted date: device was not implanted.Explanted date: device was not explanted.(b)(6).(b)(4).Two actual device pieces and 112 unused samples were returned to the manufacturing facility for evaluation.Visual inspection of the two pieces revealed that both tubes were snapped at its root, and a bend was observed at the center.Damaged portion was closely verified and the cross view of the damage was elliptically deformed.The observation describes that both tubes were forcibly tilted and bent once at its root generating a dent on the glue surface.Due to aforementioned observations, presumption explains that the tubes were bent once closely at its root, then completely snapped off as consequence.No scratches or rust were observed.The 112 unused samples of the same lot were visually checked and no irregularities including physical bent, deformation or uneven thickness, were observed.The 112 unused samples of the same lot were examined to verify elasticity of flexural strength.Every criterion was checked and through methods regulated by (b)(4)standards and every category has fulfilled the requirement.We reviewed the manufacture inspection record of the concerned lot, but no abnormal records which could be attributed to any damage to tubes, were noted.No irregular finding were observed in terms of o.D.And wall thickness of the needle.Furthermore, we have never been reported of similar events by other medical institutions.The potential for such an event is addressed in the instructions-for-use (ifu) with statements as the following: "do not bend the needle prior to use, as breakage and possible patient injury may result." (b)(4).

Event Description

The user facility reported that the needle snapped at its root while penetrating into the gum.There was no reported health hazard to the patient.

• Brand Name: TERUMO DENTAL NEEDLE
• Type of Device: NEEDLE, DENTAL
• 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: 7973483
• MDR Text Key: 124093978
• Report Number: 9681835-2018-00030
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K864970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DN-3021KL
• Device Lot Number: 160921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Date Manufacturer Received: 09/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2016
• 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