MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2019-04-12 for STREAMLINE ISS IV POLE ISS-NW manufactured by Comdel Innovation.
[141910068]
Manufacturer records investigation shows that a design revision took place on 4/25/14 where the spot type weld was changed to a full 360 degree weld at this connection point. The manufacturer records show that poles shipped before this revision would have the spot weld. There are 8 poles that shipped before the revision and the ship to location of each has been identified. Two poles have been returned from the hospital where the complaint originated. These are now on hold at (b)(4) and will be returned to the manufacturer, comdel. Three poles are on-site at the manufacturer, comdel, and will be reworked with a 360 degree weld. Three poles were shipped to distributors as demo models. The manufacturer will ship replacement poles to these distributors and the affected poles will be returned to the manufacturer to be reworked with a 360 degree weld.
Patient Sequence No: 1, Text Type: N, H10
[141910069]
A user at a hospital identified that a iv streamline pole and wing bars were tilted on the stand. Inspection found the connection point between the base and the tree section was loose. Further inspection found that the 4 very small spot welds had broke loose which is why it created a loose fitting for the iv wing bar system. Iv pole was taken out of service.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1825014-2019-00001 |
| MDR Report Key | 8510321 |
| Date Received | 2019-04-12 |
| Date of Report | 2019-04-12 |
| Date of Event | 2019-03-14 |
| Date Facility Aware | 2019-03-14 |
| Report Date | 2019-04-12 |
| Date Reported to FDA | 2019-04-12 |
| Date Reported to Mfgr | 2019-04-12 |
| Date Added to Maude | 2019-04-12 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | STREAMLINE ISS IV POLE |
| Generic Name | IV POLE |
| Product Code | FOX |
| Date Received | 2019-04-12 |
| Model Number | ISS-NW |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 6 YR |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | COMDEL INNOVATION |
| Manufacturer Address | 2100 15TH ST N WAHPETON ND 58075 US 58075 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-04-12 |