MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-10-09 for TAUT INTRADUCER PERITONEAL CATHETER PI-93 manufactured by Teleflex Medical.
[123493760]
As device was being utilized according to the manufacturer's instructions, the small silicone washer separated from the taunt introducer peritoneal catheter and fell onto sterile field following the use of the cholangiogram catheter. Washer was removed intact from the sterile field.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5080440 |
| MDR Report Key | 7951889 |
| Date Received | 2018-10-09 |
| Date of Report | 2018-10-05 |
| Date of Event | 2018-10-05 |
| Date Added to Maude | 2018-10-10 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 0 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| 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 PERITONEAL CATHETER |
| Generic Name | PERITONEAL CATHETER |
| Product Code | GBW |
| Date Received | 2018-10-09 |
| Model Number | PI-93 |
| Catalog Number | PI-93 |
| Lot Number | 73D1700302 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 0 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-10-09 |