MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 1999-08-13 for LIFESHIELD CONNECTOR 11187 manufactured by Abbott Laboratories.
[15031168]
Report rec'd from abbott international (abbott canada) that states: "as the care giver (nurse) was disconnecting the needle portion of the tubing, the rubber end of the secure lock came off and there was a splash of blood and body fluids in the nurse's face. The caregiver was seen by a dr as per normal proteocol. The nurse needed to have her eyes flushed out as result of the incident. The nurse also needed to undergo blood work because the pt was suspected to be mrs+(to be confirmed). " add'l correspondence dated 7/14/99 indicated:" as previously mentioned the nurse was exposed to a pt's blood and body fluids as result of a device malfunction. The pt was mrsa+. The main concern for the blood work is to test for hep. B and c and hiv transmission. This is done as a precautionary measure. The person is counseled by a physician to establish the risk of exposure and based on the risk assessment, the pt may be advised to take prophylactic medications. The prophylactic treatment consists of chemotherapeutic agents and the regimen is considered to be quite severe. In this particular incident, reporter does not know the physician's eval of risk, but the nurse is not taking any prophylactic medications as a result of the incident. " no add'l info is available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1018381-1999-00020 |
| MDR Report Key | 236760 |
| Report Source | 01,05,07 |
| Date Received | 1999-08-13 |
| Date of Report | 1999-07-12 |
| Date of Event | 1999-07-12 |
| Date Mfgr Received | 1999-07-12 |
| Date Added to Maude | 1999-08-25 |
| 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 | 8479350595 |
| 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 CONNECTOR |
| Generic Name | CATHETER |
| Product Code | GCE |
| Date Received | 1999-08-13 |
| Model Number | NA |
| Catalog Number | 11187 |
| Lot Number | UNK |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 229442 |
| Manufacturer | ABBOTT LABORATORIES |
| Manufacturer Address | P.O. DRAWER 1009 LAURINBURG NC 28352 US |
| Baseline Brand Name | LIFESHIELD CONNECTOR |
| Baseline Generic Name | CATHETER |
| Baseline Model No | NA |
| Baseline Catalog No | 11187 |
| 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 | 1999-08-13 |