MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,06,08 report with the FDA on 2011-08-25 for RUSCH SOFT SIMPLASTIC 3-WAY CATHETER 570622 manufactured by Teleflex.
[19102335]
The event was reported as: the irrigation port will not allow irrigation solution into the catheter - clogged. The catheter was changed out. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[19120945]
Investigation incomplete at time of this report. A f/u investigation will be submitted when completed.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2011-00128 |
| MDR Report Key | 2258043 |
| Report Source | 01,06,08 |
| Date Received | 2011-08-25 |
| Date of Report | 2011-08-12 |
| Date of Event | 2011-07-25 |
| Date Mfgr Received | 2011-08-12 |
| Device Manufacturer Date | 2011-01-01 |
| Date Added to Maude | 2011-11-16 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MARGIE BURTON, RN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9194334965 |
| Manufacturer G1 | TELEFLEX |
| Manufacturer Street | P.O. BOX 28, |
| Manufacturer City | KAMUNTING,PERAK 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH SOFT SIMPLASTIC 3-WAY CATHETER |
| Generic Name | UROLOGICAL CATHETER |
| Product Code | KOB |
| Date Received | 2011-08-25 |
| Catalog Number | 570622 |
| Lot Number | 11AE05 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-08-25 |