MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-07-19 for DIAGNOSTIC ANGIOGRAPHY PACK 89-7447 manufactured by Deroyal Industries, Inc..
[80579913]
Investigation summary: an internal complaint was received indicating that a 10 cc syringe contained within diagnostic angiography pack (finished good (b)(4), lot 44720632) cracked when drawing blood. The defective sample was not available for return. The work order for the reported lot was reviewed for discrepancies that may have contributed to the event. No discrepancies were identified. Lot mapping identified the affected component to be raw material (b)(4) -- a 10 cc syringe supplied to deroyal by (b)(4). A supplier corrective action request (scar) has been issued to (b)(4). As of the date of this report, a response has not been received. The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints, and similar complaints were identified. 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
[80579914]
A 10 cc syringe cracked while the staff was drawing blood into the syringe. The syringe was a component in an diagnostic angiography kit.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3005011024-2017-00010 |
| MDR Report Key | 6725921 |
| Report Source | USER FACILITY |
| Date Received | 2017-07-19 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-06-21 |
| Date Mfgr Received | 2017-06-21 |
| Date Added to Maude | 2017-07-19 |
| 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 | DIAGNOSTIC ANGIOGRAPHY PACK |
| Generic Name | ANGIOGRAPHY/ANGIOPLASTY KIT |
| Product Code | OEQ |
| Date Received | 2017-07-19 |
| Model Number | 89-7447 |
| Lot Number | 44720632 |
| 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 | 2017-07-19 |