MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,other, report with the FDA on 2019-03-15 for BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES 1251CSR manufactured by Bard Brachytherapy, Inc. -1424526.
[138961264]
This complaint was confirmed, and the root cause was a customer service order processing error. The device was not returned for evaluation. The lot number is unknown therefore the device history record could not be reviewed. The instructions for use were found adequate and state the following:? Indications brachysource? Seed implants are indicated for permanent interstitial treatment of selected localized tumors such as: head and neck, lung, pancreas, and early stage prostate. Brachysource? Seed implants may be used in superficial, intra-abdominal and intra-thoracic locations. Brachysource? Seed implants are indicated to treat residual tumors following completion of a course of external radiation therapy and for recurrent tumors. Contraindications as with other brachytherapy sources, treatment of tumors in generally poor condition [e. G. Ulcerated] is not recommended with brachysource? Seed implants due to the potential of brachytherapy source migration. Warnings and precautions: warning: brachysource? Seed implants contain radioactive materials. Brachysource? Seed implants, like all radioactive materials, must be handled with care. Appropriate safety measures should be used to minimize exposure to clinical personnel. Personnel monitoring is required. Typically a film badge or tld dosimeter worn on the body and a ring badge(s) is adequate. Care should be taken to minimize radiation exposure to patients and other individuals consistent with proper therapeutic management. During the implantation procedure, all practical steps should be employed to maintain radioactive exposure as low as reasonably achievable. In circumstances such as surgery when protective barriers are not practical, operators must rely upon proper use of applicators, distance and speed to minimize radiation exposure. 7,8,9,10 initiate radiation surveys on all components upon completion of the seed implant. Warning: never implant visibly damaged brachysource? Seed implants. Brachysource? Seed implants should never be handled roughly or forced into any implant device, cartridge or needle. Such force may damage the wall of the brachytherapy source, potentially causing release of i-125 into the environment or tissues surrounding an implanted. " the device was not returned.
Patient Sequence No: 1, Text Type: N, H10
[138961265]
It was reported that the seeds were shipped to surgery for urology in (b)(6) instead of (b)(6) medical center in (b)(6). The seeds had to be driven to (b)(6) medical center from (b)(6) for the scheduled implant. There was a 2-3 hour surgical delay due to the delivery error. However, the patient received their full prescribed dose.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018233-2019-01344 |
| MDR Report Key | 8425323 |
| Report Source | COMPANY REPRESENTATIVE,OTHER, |
| Date Received | 2019-03-15 |
| Date of Report | 2019-03-15 |
| Date Mfgr Received | 2019-02-21 |
| Date Added to Maude | 2019-03-15 |
| 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 | 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 | 3 |
| Brand Name | BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES |
| Generic Name | BARD? BRACHYSOURCE? I-125 IMPLANT SEEDS IN CARTRIDGES |
| Product Code | KXK |
| Date Received | 2019-03-15 |
| Model Number | 1251CSR |
| Catalog Number | 1251CSR |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| 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 | 2019-03-15 |