MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-06-06 for TAUT INTRADUCERS 10/BX7.5 FR X 3.5 PI-93 manufactured by Teleflex Medical.
[110586211]
(b)(4). The device investigation is pending. The device history review for the product taut intraducers 10/bx7. 5 fr x 3. 5 lot #73j1700667 investigation did not show issues related to the complaint. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[110586212]
It was reported that the device fell apart during the procedure, the brown plastic piece came loose. There was no patient injury,
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2018-00380 |
| MDR Report Key | 7575091 |
| Date Received | 2018-06-06 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-05-10 |
| Date Mfgr Received | 2018-06-13 |
| Device Manufacturer Date | 2017-09-27 |
| Date Added to Maude | 2018-06-06 |
| 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 | JASMINE BROWN |
| Manufacturer Street | 3015 CARRINGTON MILL BLVD |
| Manufacturer City | MORRISVILLE NC 27560 |
| Manufacturer Country | US |
| Manufacturer Postal | 27560 |
| Manufacturer Phone | 9193614124 |
| 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 | 0 |
| Brand Name | TAUT INTRADUCERS 10/BX7.5 FR X 3.5 |
| Product Code | GBW |
| Date Received | 2018-06-06 |
| Returned To Mfg | 2018-05-22 |
| Catalog Number | PI-93 |
| Lot Number | 73J1700667 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | RESEARCH TRIANGLE PARK NC |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-06 |