MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07,company representative report with the FDA on 2015-03-06 for DOUBLE-STRUNG COTTON BALLS 30-176 manufactured by Deroyal Industries, Inc..
[5747074]
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.
Patient Sequence No: 1, Text Type: D, B5
[13246167]
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.
Patient Sequence No: 1, Text Type: N, H10
[33368025]
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.
Patient Sequence No: 1, Text Type: N, H10
[33368026]
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.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010452421-2015-00001 |
| MDR Report Key | 4722978 |
| Report Source | 07,COMPANY REPRESENTATIVE |
| Date Received | 2015-03-06 |
| Date of Report | 2015-10-26 |
| Date of Event | 2015-02-05 |
| Date Mfgr Received | 2015-02-05 |
| Date Added to Maude | 2015-06-04 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | SARAH BENNETT |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8653626112 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | KM 20.5 CARRETERA A VILLA CANALES |
| Manufacturer City | VILLA CANALES, 01065 |
| Manufacturer Country | GT |
| Manufacturer Postal Code | 01065 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DOUBLE-STRUNG COTTON BALLS |
| Generic Name | COTTON, ROLL |
| Product Code | EFN |
| Date Received | 2015-03-06 |
| Catalog Number | 30-176 |
| Lot Number | 36643960 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | KM 20.5 CARRETERA A VILLA CANELES VILLA CANALES, TN 01065 GT 01065 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-03-06 |