MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED DISPOSABLE TECA CONCENTRIC NEEDLE; ELECTRODE

Model Number S53156

Device Problem Unsealed Device Packaging (1444)

Patient Problem Unspecified Infection (1930)

Event Date 12/17/2015

Event Type  malfunction  

Manufacturer Narrative

The retains log for this sn stated that this lot of needles had been taken for testing for a separate complaint, cc001300.This complaint states that there were burrs in the needles.All 25 retain needles were tested and no issues were noted.This work order has been reviewed and the seal strength test results have been investigated.The specification for a pass in seal strength is 1.2n, the results ranged from 2.508n - 3.446n for this lot which is above specification.Stock was checked on oracle for this lot number.No lots are in stock.Calibration of multitest1-d, unit to test seal strength for needle packaging, was found to be up to date.Reached out three times (18 dec, 21 dec and 04 jan) to sales rep to get more information from the complainant about the complaint.Sales rep has contacted complainant but hasn't had any response as of jan 08th.

Event Description

When doctor went ot use needle, the needle pouch was not sealed, open pouch in box.

Manufacturer Narrative

Customer has been contacted to provide the rest of the required information.We are in the process of gathering additional information.A letter listing outstanding information has been sent to customer to obtain additional information in order to submit follow up report and/or explain why required information was not provided and steps taken to obtain such information.Device not returned for evaluation.

• Brand Name: DISPOSABLE TECA CONCENTRIC NEEDLE
• Type of Device: ELECTRODE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park,; gort,; galway, connaught H91PD 92; EI H91PD92
• Manufacturer (Section G): NATUS MNAUFACTURING LIMITED; ida business park; gort; galway, connaught H91PD 92; EI H91PD92
• Manufacturer Contact: michael galvin ; ida business park; gort; galway, connaught H91PD-92 ; EI H91PD92 ; 539164700
• MDR Report Key: 5367593
• MDR Text Key: 36054131
• Report Number: 3005581270-2016-00001
• Device Sequence Number: 1
• Product Code: GXZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112034
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2018
• Device Model Number: S53156
• Device Catalogue Number: S53156
• Device Lot Number: 13C/15/TG
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/17/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/08/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Removal/Correction Number: N/A
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 65 YR