MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2017-06-07 for TAUT INTRADUCERS 10/BX7.5 FR X 3.5 PI-93 manufactured by Teleflex Medical.
[76962861]
(b)(4). The device history review for the product taut intraducers 10/bx7. 5 fr x 3. 5, lot #73k1600792 investigation did not show issues related to the complaint. The device has not been returned for investigation at this time. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[76962862]
Upon use of intraducer, during insertion of the catheter, the very small, clear disc on top of intraducer or seal fell into the patient. The customer stated that they may be hitting the disc with the edge of the catheter and pushing it through but that it has happened on three separate occasions with three different lot numbers. No patient injury or need to return for treatment, the physician is simply removing the piece then and there.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00658 |
| MDR Report Key | 6619763 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2017-06-07 |
| Date of Report | 2017-05-22 |
| Date of Event | 2017-05-17 |
| Date Mfgr Received | 2017-05-22 |
| Device Manufacturer Date | 2016-10-27 |
| Date Added to Maude | 2017-06-07 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | EFFIE JEFFERSON |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9194332672 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | RANCHO EL DESCANSO |
| Manufacturer City | TECATE 21478 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | 21478 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | TAUT INTRADUCERS 10/BX7.5 FR X 3.5 |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-06-07 |
| Catalog Number | PI-93 |
| Lot Number | 73K1600792 |
| Device Expiration Date | 2019-11-09 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-06-07 |