MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-08-31 for C-SECTION PACK 89-8636 manufactured by Deroyal Industries, Inc..
[85784064]
Investigation summary: an internal complaint (b)(4) was received indicating that a c-section pack (finished good 89-8636, lot 44274011) contained a drape with a piece of plastic on it. The affected drape was identified as a c-section drape with pouch and fenestration (b)(4). The sample was initially reported to be available for return. However, due to the contamination of the sample, it was not returned for evaluation. Instead, a photograph of the reported defect was sent. The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. Lot mapping identified the raw material drape used in the reported finished good lot was supplied to deroyal by (b)(4). Therefore, a supplier corrective action request (scar) was issued august 10, 2017, to (b)(4). The photograph of the reported defect also was sent to the supplier. The supplier acknowledged receipt of the scar on august 16, 2017. A response is due september 21, 2017. 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
[85784065]
A piece of plastic was found on a c-section drape with pouch and fenestration during a procedure. The procedure was delayed while a new pack was opened.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2017-00012 |
| MDR Report Key | 6833556 |
| Report Source | USER FACILITY |
| Date Received | 2017-08-31 |
| Date of Report | 2018-02-01 |
| Date of Event | 2017-08-03 |
| Date Mfgr Received | 2017-08-03 |
| Date Added to Maude | 2017-08-31 |
| 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 | 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 PACK |
| Generic Name | KIT, SURGICAL INSTRUMENT, DISPOSABLE |
| Product Code | KDD |
| Date Received | 2017-08-31 |
| Model Number | 89-8636 |
| Lot Number | 44274011 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-08-31 |