MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. DOUBLE-STRUNG COTTON BALLS; COTTON, ROLL

Catalog Number 30-176

Device Problems Nonstandard Device (1420); Product Quality Problem (1506); Appropriate Term/Code Not Available (3191)

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

Event Date 02/05/2015

Event Type  malfunction  

Event Description

Surgery was delayed when the end user realized the product was labeled incorrectly.The item was the wrong size - one half inch when it should have been three-eights inch.Additional info was requested related to the delay.The sales representative stated it was a matter of minutes.

Manufacturer Narrative

Investigation finding: the qfi was reviewed, it was identified that raw material (b)(4),lot number 61nd03 was utilized within the finished good and lot number reported.The raw material is supplied to deroyal by (b)(4).The 2013, 2014 and 2015 scar log was reviewed and previous reports were identified for the raw material and lot number has been received.(b)(4) has been issued.The investigation is incomplete at this time.This report will be updated as more info becomes available.

Manufacturer Narrative

Root cause analysis: gd medical supplies the raw material (part number 4-1223) to (b)(4).In its supplier corrective action request (scar), gd medical concluded the root cause to be a manufacturing error at the raw material supplier level.The cotton is produced on a machine, and it came out of the machine too loose.The gram weight of the product is fixed.Therefore, when the raw material supplier wrapped the cotton ball, the finished good was larger than normal but remained the same weight.Corrective action and/or systemic corrective action taken: gd medical identified in its scar that the raw material supplier has been notified to adhere to the technical standards.If inspectors find a product out of the specified range, they will return the affected product to the raw material supplier.Below is the more rigorous inspection process and product specifications as provided by gd medical in its scar response: "the half-processed products used to be provided by the raw material supplier as through put.Now, products were made by hand starting from raw material cotton.They were rolled up tight layer by layer.In addition, more rigorous inspection process was implemented.Each worker will randomly make (b)(4) production samples.The samples will be measured based on size and weight (please see below quality acceptance standards).If the worker passed the inspection, she would continue the manufacturing process.If not, the worker will need to show compliance with the standards before she can start the manufacturing process.(b)(4).The new inspection takes effect starting lot number 61nk14 and 61nl02 for item number 641223 as well as lot number 61nk13 for item number 641225." preventive action: gd medical identified in its scar that it is sending a business department staff member to the location to observe the process to ensure compliance.This investigation is complete.If new and critical information becomes available, this report will be updated.Device discarded by user.

Event Description

Surgery was delayed when the end user realized the product was the wrong size -- one-half inch when it should have been three-eighths inch.Additional information was requested related to the delay.The sales representative stated it was a matter of minutes.

• Brand Name: DOUBLE-STRUNG COTTON BALLS
• Type of Device: COTTON, ROLL
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a villa; caneles; villa canales, TN 01065 ; GT 01065
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 20.5 carretera a villa; canales; villa canales, 01065 ; GT 01065
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4722978
• MDR Text Key: 5747074
• Report Number: 3010452421-2015-00001
• Device Sequence Number: 1
• Product Code: EFN
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/26/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 30-176
• Device Lot Number: 36643960
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• Was Device Evaluated by Manufacturer?: No
• 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