MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-20 for TAUT INTRODUCER, 3MM X 2.4 MM X 8.9CM PI-93 manufactured by Teleflex Medical.
[73609031]
Rubber diaphragm from teleflex medical taut introducer peritoneal catheter came loose from catheter and had entered into the patient's abdominal cavity. Diaphragm was immediately retrieved and removed in its entirety from the abdominal cavity. Diagnosis or reason for use: laparoscopic cholecystectomy. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069250 |
| MDR Report Key | 6515345 |
| Date Received | 2017-04-20 |
| Date of Report | 2017-04-20 |
| Date of Event | 2017-04-19 |
| Date Added to Maude | 2017-04-24 |
| 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, 3MM X 2.4 MM X 8.9CM |
| Generic Name | PERITONEAL CATHETER |
| Product Code | GBW |
| Date Received | 2017-04-20 |
| Model Number | PI-93 |
| Catalog Number | PI-93 |
| Lot Number | 73F160026 |
| Device Expiration Date | 2019-06-30 |
| 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 | TRIANGLE PARK NC 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-20 |