MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06,07 report with the FDA on 2012-10-30 for RUSCH SIMPLASTIC 3WAY 30CC 22F 570622 manufactured by Teleflex Medical.
[3084437]
The event is reported as: alleged issue: doctor attempted to use the catheter during a procedure, but was unable to because the lumen was closed. Pt current condition is fine. Additional information has been requested.
Patient Sequence No: 1, Text Type: D, B5
[10239755]
The device sample was not received by the manufacturer at the time of this report.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8040412-2012-00174 |
| MDR Report Key | 2814503 |
| Report Source | 06,07 |
| Date Received | 2012-10-30 |
| Date of Report | 2012-10-10 |
| Date of Event | 2012-10-09 |
| Date Mfgr Received | 2012-10-10 |
| Date Added to Maude | 2013-01-23 |
| 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 | JASMINE BROWN |
| Manufacturer Street | PO BOX 12600 |
| Manufacturer City | DURHAM NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614124 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | P.O. BOX 28 |
| Manufacturer City | KAMUNTING, PERAK, WEST MALAYSIA |
| Manufacturer Country | MY |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | RUSCH SIMPLASTIC 3WAY 30CC 22F |
| Generic Name | FOLEY CATHETER |
| Product Code | KOB |
| Date Received | 2012-10-30 |
| Catalog Number | 570622 |
| Lot Number | 11JG20 |
| Operator | OTHER |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | PERAK MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2012-10-30 |