MAUDE Adverse Event Report: NATUS MANUFACTURING LIMITED DISPOSABLE MONOPOLAR NEEDLE 37MM X 28GA; ELECTRODE

Model Number 902-DMF37-TP

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Date 06/12/2015

Event Type  Injury  

Event Description

Customer reported that a pt developed an infection in their forearm three (3) days after treatment using a monopolar needle electrode.

Manufacturer Narrative

(b)(4).At design, biocompatibility testing was conducted and passed sensitivity tests per the iso 10993 standard.There have been no sterilization, material, process or chemical changes when mfg/processing the monopolar needle electrodes.The retains for this lot were inspected for weak seal patterns, open pouches, holes in the film and voids in the seal, no defects were observed.Certificate of irradiation from sterilization facility was reviewed.Sterilization parameters are correct and dose applied to this lot is within spec and product has been sterilized correctly.No quality issues associated with this lot.No rework/ sorts applicable.A review of the complaints log shows no other complaints raised for this lot.Packaging in process tests results were reviewed.Visual checks on pouch show that all passed.Seal strength test results were reviewed.All results were within spec.

Manufacturer Narrative

Serial # - this section is not applicable as the medical device does not have serial # if implanted date (mm/dd/yyyy) - this is not applicable as the medical device is not implantable.If explanted date (mm/dd/yyyy) - this is not applicable as the medical device is not implantable.Reprocessor name and address - this is not applicable as the medical device is not a single-use device that was reprocessed or reused on a patient.Also, is this a single use device that was reprocessed or reused on a pt in the initial report has ''no'', name and address of reprocessor then applicable only if ''yes'' if ind, give protocol # - this section is not applicable as the medical device is not ind.Adverse event term(s) - this section is not applicable to medical devices.If remedial action initiated, check type - this section is not applicable as no remedial action was initiated.If action reported to fda under 21 usc 360i(f), list correction/removal reporting number - this is not applicable as there was no action reported under 21 usc 360i(f) 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.The following still require information: patient identifier - awaiting customer response.Age at time of event, date of birth - awaiting customer response.Sex - awaiting customer response.Weight - awaiting customer response.Relevant tests/laboratory data, including dates - awaiting customer response.Other relevant history, including preexisting medical conditions (e.G., allergies, race, pregnancy, smoking and alcohol use, hepatic/renal dysfunction, etc.) - awaiting customer response.Concomitant medical products and therapy dates (excludes treatment of event) - awaiting customer response.Device manufacture date (mm/dd/yyyy) - awaiting customer response (lot# to identify the device manufacture date).Usage of device - awaiting customer response.

• Brand Name: DISPOSABLE MONOPOLAR NEEDLE 37MM X 28GA
• Type of Device: ELECTRODE
• Manufacturer (Section D): NATUS MANUFACTURING LIMITED; ida business park; gort, co galway ; EI
• Manufacturer Contact: michael galvin ; ida business park; gort; gort, co galway ; EI ; 091647400
• MDR Report Key: 4917831
• MDR Text Key: 6049556
• Report Number: 3005581270-2015-00001
• Device Sequence Number: 1
• Product Code: IKT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K973442
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/18/2018
• Device Model Number: 902-DMF37-TP
• Device Catalogue Number: 902-DMF37-TP
• Device Lot Number: U1503G09
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/15/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• 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
• Patient Outcome(s): Other