MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-21 for QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK? 70303QC20 manufactured by Bard Brachytherapy, Inc. -1424526.
[103286365]
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
[103286366]
It was reported that after compacting a train of extension, the seed train hung in the end of the quicklink. It was noted that the tip of the extension was crushed. Two attempts later, the expansion bar was changed to eliminate a batch problem, however the issue persisted. The quicklink was then changed, and so was the extension bar, in addition to compressing the grain train at a slower pace.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00893 |
| MDR Report Key | 7356729 |
| Date Received | 2018-03-21 |
| Date of Report | 2018-05-18 |
| Date of Event | 2018-02-19 |
| Date Mfgr Received | 2018-05-18 |
| Device Manufacturer Date | 2017-09-22 |
| Date Added to Maude | 2018-03-21 |
| 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 | PHARMACIST |
| 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 | QUICKLINK? CARTRIDGE 5.0MM EXTENSION SOURCELINK? |
| Generic Name | BRACHYTHERAPY |
| Product Code | KXK |
| Date Received | 2018-03-21 |
| Model Number | 70303QC20 |
| Catalog Number | 70303QC20 |
| Lot Number | BBBV0102 |
| Device Expiration Date | 2018-04-01 |
| 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 | 2018-03-21 |