MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-11-13 for C-SECTION TRACEPACK 89-9338 manufactured by Deroyal Industries, Inc..
[129160289]
Investigation summary: an internal complaint (call (b)(4)) was received for a custom procedure pack (finished good 89-9338, lot 48053224) that contained a cautery pencil that arced during use. A sample was returned november 2, 2018 to deroyal. Due to the nature of the complaint, the samples could not be tested at deroyal's lafollette facility to validate the end user's report. The samples were forwarded november 5, 2018 to the pencil manufacturer. The complaint investigator reviewed the work order for possible discrepancies that may have contributed to the reported issue. No discrepancies were identified. The bill of materials was reviewed for the finished kit and the affected component was identified as raw material (b)(4) (lot 80860193x). This raw material is supplied to deroyal by covidien. The supplier corrective action requests (scar) and supplier notification letter logs were reviewed for similar complaints for the time period of 2016 to present. Similar incidents were found, and a scar and the returned samples were sent to covidien. As of the date of this report, a response has not been received. Deroyal will continue to monitor post-market feedback and will recognize in the future if the issue reoccurs. The investigation is incomplete at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[129160290]
A convenience kit contained a cautery pencil that arced during use. It was connected to a bovie generator. No injury was reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00008 |
| MDR Report Key | 8063734 |
| Date Received | 2018-11-13 |
| Date of Report | 2019-02-05 |
| Date of Event | 2018-10-17 |
| Date Mfgr Received | 2018-10-17 |
| Date Added to Maude | 2018-11-13 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| 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 | 1501 EAST CENTRAL AVENUE |
| Manufacturer City | LAFOLLETTE TN 37766 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37766 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | C-SECTION TRACEPACK |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2018-11-13 |
| Returned To Mfg | 2018-11-02 |
| Model Number | 89-9338 |
| Lot Number | 48053224 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | DEROYAL INDUSTRIES, INC. |
| Manufacturer Address | 1501 EAST CENTRAL AVENUE LAFOLLETTE TN 37766 US 37766 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-11-13 |