MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-01-11 for C-SECTION TRACEPACK 89-9338 manufactured by Deroyal Industries, Inc..
[134371403]
Investigation summary: an internal complaint ((b)(4)) was received for a convenience kit (finished good 89-9338, lot 47970039) that contained a cautery pencil that malfunctioned during use. The pencil reportedly had an electrical arc. Samples were returned for evaluation and forwarded to the component supplier for review. 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 for the finished good kit was reviewed and the affected component was identified as a hand control pencil with a coated blade (raw material (b)(4)). This pencil is supplied to deroyal by (b)(4). The 2016-2018 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. Similar non-conformances were found and a scar was issued to (b)(4). As of the date of this report, a response has not been received. The investigation is ongoing at this time. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[134371404]
A convenience kit contained a cautery pencil that malfunctioned during use and reportedly had an electrical arc.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00017 |
| MDR Report Key | 8239717 |
| Report Source | USER FACILITY |
| Date Received | 2019-01-11 |
| Date of Report | 2019-02-27 |
| Date of Event | 2018-12-12 |
| Date Mfgr Received | 2018-12-12 |
| Date Added to Maude | 2019-01-11 |
| 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 | 3 |
| Brand Name | C-SECTION TRACEPACK |
| Generic Name | DISPOSABLE SURGICAL INSTRUMENT KIT |
| Product Code | KDD |
| Date Received | 2019-01-11 |
| Returned To Mfg | 2018-12-27 |
| Model Number | 89-9338 |
| Lot Number | 47970039 |
| 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 | 2019-01-11 |