MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06 report with the FDA on 2012-11-21 for DEROYAL 89-7447 manufactured by Jiangsu Shenli Medical Production.
[3057686]
The hospital reported that the syringe split when pressured to clear a catheter filled with blood. This is a normal procedure. The syringe had a hairline fracture in the side and blood spurted into the face of the provider.
Patient Sequence No: 1, Text Type: D, B5
[10467499]
Describe event or problem: the hospital reported that the syringe split when pressured to clear a catheter filled with blood. This is a normal procedure. The syringe had a hairline fracture in the side and blood spurted into the face of the provider. Deroyal: the defective raw material number in this 89-7447 angiography pack is 5-20055 syringe 10cc luer lock ((b)(4)). Investigation into the root cause is still in process.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005011024-2012-00006 |
| MDR Report Key | 2897586 |
| Report Source | 00,06 |
| Date Received | 2012-11-21 |
| Date of Report | 2012-10-25 |
| Date of Event | 2012-10-09 |
| Date Facility Aware | 2012-10-09 |
| Date Reported to FDA | 2012-10-12 |
| Date Reported to Mfgr | 2012-10-25 |
| Date Mfgr Received | 2012-10-25 |
| Device Manufacturer Date | 2012-06-01 |
| Date Added to Maude | 2013-02-27 |
| 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 | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 200 DEBUSK LANE |
| Manufacturer City | POWELL TN 37849 |
| Manufacturer Country | US |
| Manufacturer Postal | 37849 |
| Manufacturer Phone | 8002519864 |
| Manufacturer G1 | DEROYAL INDUSTRIES, INC. |
| Manufacturer Street | 1501 EAST CENTRAL AVE. |
| 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 | DEROYAL |
| Generic Name | FMF - SYRINGE, PISTON |
| Product Code | GDX |
| Date Received | 2012-11-21 |
| Returned To Mfg | 2012-11-05 |
| Model Number | 89-7447 |
| Lot Number | 29484993 |
| Device Expiration Date | 2017-06-11 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | JIANGSU SHENLI MEDICAL PRODUCTION |
| Manufacturer Address | CH |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2012-11-21 |