MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,other report with the FDA on 2020-02-07 for BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS 1251QCL2 manufactured by C.r. Bard, Inc. (covington) -1018233.
[183914682]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed.
Patient Sequence No: 1, Text Type: N, H10
[183914683]
It was reported that there were several empty shots with 20 seed cartridges. Each time the cartridge was removed and inserted into the loader carriage the plunger was not going down. Per additional information from the ibc via email 23jan2020, it was unknown if the procedure was delayed or canceled due to the event described. No additional medication or sedative was used on the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-00858 |
| MDR Report Key | 9681474 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-02-07 |
| Date of Report | 2020-02-07 |
| Date of Event | 2020-01-15 |
| Date Mfgr Received | 2020-01-15 |
| Date Added to Maude | 2020-02-07 |
| 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 | YONIC ANDERSON |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal | 30014 |
| Manufacturer Phone | 7707846100 |
| Manufacturer G1 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Street | 8195 INDUSTRIAL BLVD |
| Manufacturer City | COVINGTON GA 30014 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 30014 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BARD? QUICKLINK? CARTRIDGES WITH BRACHYSOURCE? I-125 SEEDS |
| Generic Name | BRACHY SOURCE SEED |
| Product Code | KXK |
| Date Received | 2020-02-07 |
| Returned To Mfg | 2020-01-27 |
| Catalog Number | 1251QCL2 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-07 |