MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-21 for TAUT INTRODUCER PERITONEAL CATHETER PI-93 manufactured by Teleflex Medical.
[121618093]
Small silicone washer fell out of the taut introducer peritoneal catheter into the pt's abdomen. Surgeon was able to retrieve the washer. Only washer / seal and packaging retained by staff.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080054 |
| MDR Report Key | 7901794 |
| Date Received | 2018-09-21 |
| Date of Report | 2018-09-20 |
| Date of Event | 2018-09-19 |
| Date Added to Maude | 2018-09-24 |
| 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 INTRODUCER PERITONEAL CATHETER |
| Generic Name | PERITONEAL CATHETER |
| Product Code | GBW |
| Date Received | 2018-09-21 |
| Model Number | PI-93 |
| Catalog Number | PI-93 |
| Lot Number | 73E1700181 |
| 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 | 2018-09-21 |