MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. BREAST PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 89-8797

Device Problems Degraded (1153); Flaked (1246); Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2016

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (b)(4) was received indicating that a breast pack (finished good 89-8797, lot number 42333031) contained an electrosurgical tip (raw material (b)(4) on which the coating was coming off.The defective sample has been returned for evaluation.The evaluation is ongoing at this time.The work order was reviewed and it was identified the raw material is produced at deroyal (b)(4).The raw material manufacturer has been notified to assist in the evaluation and complaint investigation.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The customer reported the coating is coming off the electrosurgical tip in the pack.The physician staff is worried about the coating going into the patients.

Manufacturer Narrative

Root cause: the root cause was determined to be a defect in the raw material (electrode, raw material part (b)(4)), which is supplied to deroyal by modern medical.Corrective action: in response to a supplier corrective action request (scar), modern medical stated that no further action other than continuous monitoring was needed.Investigation summary an internal complaint (call (b)(4)) was received indicating that a breast pack (finished good (b)(4), lot number 42333031) contained an electrosurgical tip (raw material (b)(4)) on which the coating was coming off.Defective samples were received and evaluated.A visual inspection of the received samples confirmed the coating was coming off.The work order was reviewed and it was identified that raw material (b)(4) is produced at deroyal cientifica in (b)(6).The raw material lot was identified as (b)(4).The work order for this raw material lot was reviewed, and it was confirmed that no issues were reported during the manufacturing process.Deroyal cientifica manufactures the cautery pencil, but the electrode placed onto the pencil is supplied by modern medical.The raw material part number for the electrode is (b)(4).The electrode is not inspected during the manufacturing process of the cautery pencil as the supplied electrode comes with a plastic protector.The manufacturing process at deroyal cientifica consists of inserting the electrode into the pencil and performing a continuity test.In its scar response, modern medical stated it performed a simulation test on a retained sample and found the tip of the electrode slightly charred.However, the tip coating did not come off during the simulation.A general cleaning simulation was then performed after the simulation test.The vendor found there were scratches in the coating on the retained samples following the cleaning simulation, but when compared with the defective samples, the scratches to the coating were more serious on the defective samples.The complaint log was reviewed for a period of two years.No similar issues were identified.The material review reports (mrr) log also was reviewed for a period of two years, and no similar issues were identified.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The customer reported the coating is coming off the electrosurgical tip in the pack.The physician staff is worried about the coating going into the patients.

• Brand Name: BREAST PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5847572
• MDR Text Key: 51201797
• Report Number: 3005011024-2016-00020
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-8797
• Device Lot Number: 423333031
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/05/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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