MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2001-05-21 for PERCUPUMP CT INJECTOR W/EDA 8805 NA manufactured by E-z-em, Inc..
[208350]
Facility reported that a pt with large fleshy arms presented for a ct scan. Following venupuncture, the standard drawback of blood was performed and venous access was confirmed. The injector was set a flow rate of approximately 1. 4 cc/sec. And a total volume of 140ml of contrast was injected. During the scan no contrast appeared in the area of interest or in the kidneys. There was no visible swelling at the injection site, but a mass of fluid was palpable at depth in the tissue. The radiology department was not aware of subsequent treatment or pt condition.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2432460-2001-00007 |
| MDR Report Key | 334567 |
| Report Source | 05,06,07 |
| Date Received | 2001-05-21 |
| Date of Report | 2001-04-17 |
| Date of Event | 2001-04-04 |
| Date Facility Aware | 2001-04-04 |
| Report Date | 2001-04-17 |
| Date Reported to Mfgr | 2001-04-17 |
| Date Mfgr Received | 2001-04-17 |
| Device Manufacturer Date | 1999-09-01 |
| Date Added to Maude | 2001-05-29 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | JUDITH MERITZ, VP |
| Manufacturer Street | 717 MAIN STREET |
| Manufacturer City | WESTBURY NY 11590 |
| Manufacturer Country | US |
| Manufacturer Postal | 11590 |
| Manufacturer Phone | 8005444624 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PERCUPUMP CT INJECTOR W/EDA |
| Generic Name | CT INJECTOR WITH EXTRAVASATION ACCESSORY |
| Product Code | FIH |
| Date Received | 2001-05-21 |
| Model Number | 8805 |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 20 MO |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 323911 |
| Manufacturer | E-Z-EM, INC. |
| Manufacturer Address | 113-117 MAGNOLIA AVE. WESTBURY NY 11590 US |
| Baseline Brand Name | PERCUPUMP TOUCHSCREEN INJECTOR W/EDA |
| Baseline Generic Name | CT INJECTOR SYSTEM |
| Baseline Model No | NA |
| Baseline Catalog No | 8805 |
| Baseline ID | NA |
| Baseline Device Family | PERCUPUMP INJECTOR SYSTEM |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K961845 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2001-05-21 |