MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2005-05-18 for TRIMLINE * 9204 manufactured by Trimline Medical Products.
[17488730]
The pt was connected to a philips monitor, which includes ekg, rr, spo2, and nibp. The pt took the nibp hose and connected this to his iv tubing at the clave connection by utilizing the dual tube adapter applied to the cable. Had this not been discovered before the machine cycled, the pt could have sustained a fatal air embolus. Originally these adapters made and supplied by trimline. Part# 9204, adapts single tube bayonet to dual tube male -push-luer, so that the facility could utilize just one type of disposable cuffs with all of our makes and models of nibp products. We have changed out our disposable cuffs for those with bayonet for single tube applications only, removed and destroyed all dual adapters.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW1035531 |
| MDR Report Key | 742619 |
| Date Received | 2005-05-25 |
| Date of Report | 2005-05-18 |
| Date of Event | 2005-04-20 |
| Date Added to Maude | 2006-08-02 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TRIMLINE |
| Generic Name | 9204 ADAPTER - SINGLE TUBE MALE BAYONET TO DUAL TUBE MALE LU |
| Product Code | FKB |
| Date Received | 2005-05-18 |
| Model Number | * |
| Catalog Number | 9204 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 730457 |
| Manufacturer | TRIMLINE MEDICAL PRODUCTS |
| Manufacturer Address | 34 COLUMBIA RD BRANCHBURG NJ 08876 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Life Threatening; 2. Required No Informationntervention | 2005-05-25 |