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 2020-02-13 for I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE 1251QCSCE manufactured by C.r. Bard, Inc. (covington) -1018233.
[183294892]
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
[183294893]
It was reported that on tuesday the 16th during the manufacture of a grain train, a grain was stuck in the cassette while it was being inserted. It was not the first grain delivered. The cassette was changed, and there was still the same problem. After 3 or 4 grains, the cassette got stuck again. On the 23rd, it was the same problem except there was only one cassette. The cassette had to be emptied by hand, and the beans had to be inserted into the quick link by hand.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2020-01047 |
| MDR Report Key | 9708300 |
| Report Source | HEALTH PROFESSIONAL,OTHER |
| Date Received | 2020-02-13 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-01-16 |
| Date Mfgr Received | 2020-02-12 |
| Date Added to Maude | 2020-02-13 |
| 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 | 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 | I-125 QUICKLINK CARTRIDGE (IN PEWTER TRAY), STERILE |
| Generic Name | QUICKLINK LOADER |
| Product Code | KXK |
| Date Received | 2020-02-13 |
| Catalog Number | 1251QCSCE |
| Lot Number | 554140SL |
| 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 | 2020-02-13 |