MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2000-06-26 for LIFESHIELD DUAL INJECTION SITE SEVICE 11536 manufactured by Abbott Laboratories.
[15005095]
Report rec'd of leakage of solution from the injection port around the needle entry point. Customer states that they "frequently" have problems in the nuclear cardiology department with injection of radioactive isotope materials such as thallium. Throughout the slow push injection. There is leaking of the material from around the needle. The leakage falls on linens which are appropriately taken care of per protocol. The injection ports have not been punctured prior to the procedure. There has been no exposure with the solutions to a pt or employee, however, the customer is concerned about the potential for exposure. The nuclear medicine departments use sharp 20 gauge needles for injection and insert directly into the center of the target on the port. No add'l info was available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018381-2000-00032 |
| MDR Report Key | 284148 |
| Report Source | 05 |
| Date Received | 2000-06-26 |
| Date of Report | 2000-05-25 |
| Date of Event | 2000-05-01 |
| Date Mfgr Received | 2000-05-25 |
| Device Manufacturer Date | 1999-12-01 |
| Date Added to Maude | 2000-07-05 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | NANCY CONWAY, DIRECTOR |
| Manufacturer Street | DEPT 389,AP30 200 ABBOTT PARK RD |
| Manufacturer City | ABBOTT PARK IL 600646157 |
| Manufacturer Country | US |
| Manufacturer Postal | 600646157 |
| Manufacturer Phone | 8479374085 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | LIFESHIELD DUAL INJECTION SITE SEVICE |
| Generic Name | CATHETER |
| Product Code | GCE |
| Date Received | 2000-06-26 |
| Model Number | NA |
| Catalog Number | 11536 |
| Lot Number | 60155HG |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 274976 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | P.O. DRAWER 1009 LAURINBURG NC 28352 US |
| Baseline Brand Name | LIFESHIELD DUAL INJECTION SITE DEVICE |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 11536 |
| Baseline ID | NA |
| Baseline Device Family | ADAPTER, CATHETER |
| Baseline Shelf Life Contained | * |
| Baseline Shelf Life [Months] | * |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K912103 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-26 |