MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2018-07-20 for CUSTOM ANGIOGRAPHY PACK 89-9920 manufactured by Deroyal Industries, Inc..
[114693845]
Investigation summary: an internal complaint (b)(4) was received for a custom angiography kit (part number 89-9920, lot 47018603) that contained a defective syringe. The syringe contained a burr that led to a hospital employee sustaining a minor injury. Representative samples of the syringe were returned to deroyal for evaluation. The actual defective sample was discarded by the end user. The representative samples did contain small burrs; however, the complaint investigator found these burrs were not sharp enough to break skin as reported in the initial complaint. The complaint investigator reviewed the work order for the reported lot for discrepancies that may have contributed to the reported event. No discrepancies were identified. The bill of materials for the finished kit was reviewed and raw material (b)(4) was identified as the defective syringe. This syringe is supplied to (b)(4) by (b)(4). A review of the 2016-2018 supplier corrective action requests (scar) and supplier notification letters showed similar complaints for this syringe. Therefore, a scar was issued to (b)(4). The representative samples of the defective syringe also were forwarded to the manufacturer for review. 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
[114693846]
An employee was injured from burrs on the plunger wings of a syringe. The burr ripped through two pairs of gloves and cut the skin.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2018-00003 |
| MDR Report Key | 7707922 |
| Report Source | USER FACILITY |
| Date Received | 2018-07-20 |
| Date of Report | 2018-09-06 |
| Date of Event | 2018-06-20 |
| Date Mfgr Received | 2018-06-20 |
| Date Added to Maude | 2018-07-20 |
| 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 | CUSTOM ANGIOGRAPHY PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2018-07-20 |
| Returned To Mfg | 2018-06-25 |
| Model Number | 89-9920 |
| Lot Number | 47018603 |
| 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 | 2018-07-20 |