MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-07-23 for FASTLOAD CTA 6730 017347 manufactured by Bracco Injennering Sa.
[6633926]
Product defect in manufacturing of the fastload cta dual syringe pack used in the empower cta and empower cta injector systems. Two of three packages had the locking lugs on the syringe broken off. One of three had the low pressure connecting y-tube blue cap crushed and torn off. These all occurred in the same lot number. None were used on any patients, however, the broken locking lugs on the syringes made them unusable. None of the other dual packs in stock with this lot number had the same defect. Attempts were made to duplicate the error by dropping the packages from 5 feet to the floor. There was no damage. Fastload cta dual syringe pack with spikes contains: 2x 200ml fastload syringes, 1 low pressure connecting t tube, 1 small spike and 1 large spike.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5044858 |
| MDR Report Key | 4949666 |
| Date Received | 2015-07-23 |
| Date of Report | 2015-07-23 |
| Date of Event | 2015-07-22 |
| Date Added to Maude | 2015-07-30 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 | 0 |
| Event Location | 0 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FASTLOAD CTA |
| Generic Name | INJECTOR SYSTEM |
| Product Code | DXT |
| Date Received | 2015-07-23 |
| Model Number | 6730 |
| Catalog Number | 017347 |
| Lot Number | IADA4-1505 |
| Device Expiration Date | 2018-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENNERING SA |
| Manufacturer Address | LAUSANNE SZ |
| Brand Name | FASTLOAD CTA |
| Generic Name | INJECTOR SYSTEM |
| Product Code | IZQ |
| Date Received | 2015-07-23 |
| Model Number | 6730 |
| Catalog Number | 017347 |
| Lot Number | IADA4-1505 |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING SA |
| Manufacturer Address | LUSANNE, CH SZ |
| Brand Name | FASTLOAD CTA |
| Generic Name | INJECTOR SYSTEM |
| Product Code | IZQ |
| Date Received | 2015-07-23 |
| Model Number | 6730 |
| Catalog Number | 017347 |
| Lot Number | IADA4-1505 |
| Device Expiration Date | 2018-05-31 |
| Device Sequence No | 3 |
| Device Event Key | 0 |
| Manufacturer | BRACCO INJENEERING SA |
| Manufacturer Address | LAUSANNE, CH SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-07-23 |