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 2020-02-14 for BARD? QUICKLINK? CARTRIDGES 1251QCS manufactured by C.r. Bard, Inc. (covington) -1018233.
[183258661]
The investigation is still in progress. Once the investigation is complete, a supplemental report will be filed. The device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[183258662]
It was reported that the plunger on the seed cartridge did not descend at all. Per additional information from the ibc via email 04feb2020, the procedure took longer than usual. The seeds were taken from the cartridge and manually loaded one at the time into the loader assembly base. Per additional information from the ibc via email 06feb2020, there was no additional medication of any kind required to finish the procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01072 |
| MDR Report Key | 9714135 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-02-14 |
| Date of Report | 2020-03-30 |
| Date of Event | 2020-01-23 |
| Date Mfgr Received | 2020-03-25 |
| Date Added to Maude | 2020-02-14 |
| 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 |
| Generic Name | QUICK LINK SEED LINKER |
| Product Code | KXK |
| Date Received | 2020-02-14 |
| 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 | C.R. BARD, INC. (COVINGTON) -1018233 |
| Manufacturer Address | 8195 INDUSTRIAL BLVD COVINGTON GA 30014 US 30014 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-14 |