MAUDE Adverse Event Report: DEROYAL INDUSTRIES MASTOID PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-7083

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 10/30/2014

Event Type  malfunction  

Event Description

Connector female, leaks and is a danger to the sterile field.

Manufacturer Narrative

Investigation findings: the work order review did not identify any discrepancies.Raw material (b)(4) lot number 41058076x was contained within the finished good.The raw material is supplied to deroyal by (b)(4).Scar2014-449kjg was issued to (b)(4) in reference to the complaint.(b)(4) is a known vendor that requires additional time beyond the 15 day scar due date.The qc complaint specialist followed up with the reporting customer, (b)(6), to request additional info in reference to the complaint.The product is being utilized with tubing and connected to a drill during the procedure.It is currently unk as to the type of tubing being utilized and the replacement connector being utilized by the end user has not been identified.The reporting customer identified that they will obtain the info and re-contacts the qc complaint specialist on (b)(6) 2014 with the info.Samples will be provided of the female connector, tubing, and replacement connector being utilization by the end user.The qc complaint specialist requested a ups call tag.No further info is available at this time.Will provide follow ups if info becomes available.

Manufacturer Narrative

(b)(4).(b)(6), to request additional information in reference to the complaint.The product is being utilized with tubing and connected to a drill during the procedure.It is currently unknown as to the type of tubing being utilized and the replacement connector being utilized by the end user has not been identified.The reporting customer identified that they will obtain the information and recontact the qc complaint specialist on (b)(6) 2014 with the information.Samples will be provided of the female connector, tubing, and replacement connector being utilized by the end user.The qc complaint specialist requested a ups call tag be issued to the end user for the sample retrieval.The representative samples were received on 11/05/2014.It was confirmed that the female luer lock connector being utilized by the end user as a replacement to the connector contained within the tray are the same raw material products supplied by the same vendor.Deroyal removes the product from the vendor packaging as part of the manufacturing process.The component evaluation form was reviewed and it was confirmed that the vendor has indicated the raw material product can be sterilized a second time utilizing eto sterilization.Eto sterilization is the method utilized by deroyal to sterilize the device.No previous reports have been entered into the deroyal quality system and the 2012--2014 scar/snl.Logs were reviewed.No previous issues have been identified for the raw material.The bom where used report was reviewed.The raw material is utilized only in the two finished good products identified by the reporting customer.(b)(4) was issued to (b)(4) in reference to the complaint.(b)(4) is a known vendor that requires additional time beyond the 15-day scar due date.An additional follow-up in reference to the outstanding scar was performed on (b)(6) 2014.On (b)(6) 2014, a (b)(4) representative provided conformation of the receipt of the scar on (b)(6) 2014.Refer to the attachment as evidence.An additional follow-up for the complaint investigation was completed on (b)(6) 2014.The scar response was received and evaluated on 05/04/2015.As part of the vendor investigation, it was identified that the device history record file was reviewed indicating that the product was released meets all quality standard requirements.There were no related non-conforming issues reported during the manufacturing of this product for a similar condition as reported in this complaint.Evaluation of the five samples returned did not leak at the connector.The process is running according to product specification meeting quality acceptance criteria.The production personnel were notified about the reported condition.Correction: a correction has not been taken.Root cause analysis: scar: five samples were received for evaluation and after a visual and functional inspection, the reported issue was not observed.Therefore, a root cause for the reported issue is not deemed necessary at this time.Corrective action and/or systemic correction action taken: scar: based on the information available, a corrective action is noted deemed to be necessary at this time.If additional information is received warranting further analysis, the investigation will be resumed.This complaint will be used for tracking and trending purposes.Appropriate manufacturing and quality assurance personnel have been made aware of this complaint in an effort to focus attention on the issue.Preventive action: scar: a preventive action has not been taken by the vendor.The investigation is complete at this time.This report will be updated if more information becomes available.

Event Description

Connector female leaks and is a danger to the sterile field.

• Brand Name: MASTOID PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 1501 east central ave.; lafollette TN 37766
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653622333
• MDR Report Key: 4321846
• MDR Text Key: 16848421
• Report Number: 3005011024-2014-00015
• Device Sequence Number: 1
• Product Code: KDD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Not Applicable
• Type of Report: Initial,Followup
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2015
• Device Catalogue Number: 89-7083
• Device Lot Number: 36574621
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/30/2014
• Event Location: Hospital
• Date Manufacturer Received: 10/30/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2014
• 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): Required Intervention