MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-03-13 for QUICKLINK? LOADER 70310QCA1 manufactured by Bard Brachytherapy, Inc. -1424526.
[102337948]
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.
Patient Sequence No: 1, Text Type: N, H10
[102337949]
It was reported that during a 3/4 curietherapie procedure there was a problem with the quicklink applicator. It had blocked due to the failure to tighten a screw located under the rack, preventing the advance of the needle. The screw was loosened during the procedure since the tests and the preparation of 12 needles before had been carried out without difficulty. The customer had to take a new applicator to complete the procedure. There was an extended operating time for the patient of about 10 minutes.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2018-00797 |
| MDR Report Key | 7336173 |
| Date Received | 2018-03-13 |
| Date of Report | 2018-03-21 |
| Date of Event | 2018-02-22 |
| Date Mfgr Received | 2018-03-20 |
| Date Added to Maude | 2018-03-13 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| 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? LOADER |
| Generic Name | QUICKLINK LOADER |
| Product Code | IWJ |
| Date Received | 2018-03-13 |
| Returned To Mfg | 2018-03-09 |
| Catalog Number | 70310QCA1 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | * |
| 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 | 2018-03-13 |