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

Catalog Number DN*2735B

Device Problems Fracture (1260); Off-Label Use (1494); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Code Available (3191)

Event Date 09/01/2014

Event Type  Injury  

Event Description

The user facility reported that a dental needle broke at the hub when it was removed from the patient's cervix.The needle was removed using an endoscope.The patient's condition is unknown and no other event details have been provided by the user facility.

Manufacturer Narrative

(no code available) an additional endoscopic procedure was required to retrieve the detached material, but there is no code available.The actual device was returned and evaluated.Visual inspection confirmed that the needle tubing was broken at the base where glue is applied.It was also found that the needle tubing was bent 13mm from the broken base.The broken base was inspected under a microscope and it showed that the damaged section was extended and thin and had an oval shape indicating that the tubing was repeatedly bent which would cause the device to fracture.A review of the device history record confirmed that there were no production related problems for this lot number.Based on user facility information and the investigation findings, there is no indication that this event was related to a device defect or malfunction.The available information confirms that the device was not used for its intended purpose.All available information has been placed on file in quality assurance for tracking, trending, and follow up.(b)(4).

• Type of Device: DENTAL NEEDLE
• Manufacturer (Section D): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409- 3583; JA 409-3583
• Manufacturer (Section G): TERUMO CORPORATION - KOFU; 1727-1, tsuiji-arai; showa-cho; nakakoma-gun, yamanashi 409- 3583; JA 409-3583
• Manufacturer Contact: cathleen hargreaves ; 950 elkton blvd.; elkton, MD 21921 ; 8002837866
• MDR Report Key: 4120674
• MDR Text Key: 4945404
• Report Number: 9681835-2014-00024
• Device Sequence Number: 1
• Product Code: DZM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K864970
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/02/2014,09/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2014
• Device Catalogue Number: DN*2735B
• Device Lot Number: 091110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/01/2014
• Device Age: 59 MO
• Event Location: Hospital
• Date Report to Manufacturer: 09/02/2014
• Date Manufacturer Received: 09/02/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2009
• 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
• Treatment: ENDOSCOPE
• Patient Outcome(s): Required Intervention