MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-12 for BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS 1251QCS manufactured by Bard Brachytherapy, Inc. -1424526.
[97857742]
The investigation is still in progress. Once the investigation is complete a supplemental report will be filed. The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[97857743]
It was reported that the new cartridge and pressing the normal seed button on the loader felt fine but nothing came out, as confirmed by opening the second button (relay end) and inserting a needle. The carrier was completely jammed. After several more tries, the button did release and everything appeared to be freed up again but there was still no sign of a seed expelled. Tried to expel another seed and everything completely jammed as above but this time nothing could be released at all, including the cartridge which at this point showed that 3-5 seeds had been ejected somewhere. We changed to the other loader and continued to the end with another cartridge, number 4, which was fine. At the end of the procedure everything was still jammed but we managed to remove the cartridge assembly and there were 4 seeds within the loader, 1 on the baseplate, 2 on top of each other within the? Blade? Mechanism which were jamming everything up. They were stuck but could be removed with tweezers as they were really only jamming themselves in. The final 1 seed, with all of the moving of the various mechanisms and stylet had moved into the normal channel.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00122 |
| MDR Report Key | 7185883 |
| Date Received | 2018-01-12 |
| Date of Report | 2018-01-25 |
| Date Mfgr Received | 2018-01-19 |
| Date Added to Maude | 2018-01-12 |
| 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 | AMY GRAVLEY |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Street | 295 EAST LIES ROAD |
| Manufacturer City | CAROL STREAM IL 60188 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 60188 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS |
| Generic Name | BRACHY CARTRIDGE |
| Product Code | KXK |
| Date Received | 2018-01-12 |
| Model Number | 1251QCS |
| Catalog Number | 1251QCS |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | BARD BRACHYTHERAPY, INC. -1424526 |
| Manufacturer Address | 295 EAST LIES ROAD CAROL STREAM IL 60188 US 60188 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-12 |