MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2019-03-29 for ANGIOGRAPHY KIT 89-9920 manufactured by Deroyal Industries, Inc..
[146102009]
Investigation summary: an internal complaint ((b)(4)) was received indicating an angiography kit (part 89-9920, lot 48815217) contained a syringe with a sharp flange that led to a technician sustaining a minor injury. This occurred during a procedure and also caused the technician's glove to be contaminated. Two syringes were returned march 7, 2019, to deroyal. Barbs were observed on both of the returned syringes, confirming the reported issue. The work order for the finished good kit was reviewed for discrepancies that may have contributed to the reported event. No discrepancies were identified. The bill of materials was reviewed and raw material (b)(4) (syringe 20cc) was identified as the affected kit component. This syringe is supplied to deroyal by becton-dickinson. The 2017-2019 supplier corrective action request (scar) and supplier notification letter logs were reviewed for similar complaints. Similar reports were identified, and a scar was issued to becton-dickinson. The affected sample also was forwarded. As of the date of this report, a scar response has not been received. The investigation is ongoing. When new and critical information is received, this report will be updated.
Patient Sequence No: 1, Text Type: N, H10
[146102010]
There was a sharp edge on the flange of a syringe. When pushing the plunger in, a technician was stuck with the sharp edge, causing bleeding and contaminating the glove. This occurred during a procedure. The affected syringe was packaged in a convenience kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2019-00004 |
| MDR Report Key | 8464727 |
| Report Source | USER FACILITY |
| Date Received | 2019-03-29 |
| Date of Report | 2019-05-03 |
| Date of Event | 2019-03-01 |
| Date Mfgr Received | 2019-03-01 |
| Date Added to Maude | 2019-03-29 |
| 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 | ANGIOGRAPHY KIT |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2019-03-29 |
| Returned To Mfg | 2019-03-07 |
| Model Number | 89-9920 |
| Lot Number | 48815217 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 | 2019-03-29 |