MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-12 for TAUT INTRADUCER PL-93 manufactured by Teleflex Medical.
[111080019]
With initial use of the teleflex. Taut intraducer peritoneal catheter, the small rubber seal detached from the device and was retrieved from within the pt's abdomen.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5077802 |
| MDR Report Key | 7596093 |
| Date Received | 2018-06-12 |
| Date of Report | 2018-06-11 |
| Date of Event | 2018-06-08 |
| Date Added to Maude | 2018-06-13 |
| 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 |
| 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 | TAUT INTRADUCER |
| Generic Name | PERITONEAL CATHETER |
| Product Code | GBW |
| Date Received | 2018-06-12 |
| Model Number | PL-93 |
| Lot Number | 73K1700687 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-12 |