MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-04 for ANGIOGRAPHY PACK 89-7019 manufactured by Deroyal Industries, Inc..
[74497163]
Investigation summary an internal complaint (b)(4) was received indicating that a 10cc syringe contained within an angiography pack (part number 89-7019) split down the side, allowing facility staff to become exposed to blood. A sample was not available for return. The syringe is supplied to deroyal by (b)(4). Therefore, a supplier corrective action request was issued to (b)(4) on april 20, 2017. A response is due june 1, 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
[74497244]
A 10cc syringe contained within the angiography pack splint down the side, allowing the surgeon and tech to be exposed to blood.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2017-00007 |
| MDR Report Key | 6545985 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-04 |
| Date of Report | 2018-01-19 |
| Date of Event | 2017-04-13 |
| Date Mfgr Received | 2017-04-13 |
| Date Added to Maude | 2017-05-04 |
| 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 | 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 | ANGIOGRAPHY PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2017-05-04 |
| Model Number | 89-7019 |
| Lot Number | 44357626 |
| 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 | 2017-05-04 |