MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-20 for TAUT INTRADUCERS 10/BX7.5 FR X 3.5 PI-93 manufactured by Teleflex Medical.
[70641457]
(b)(4). The facility has communicated that the device is not available for evaluation. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[70641458]
The inner lining of a taut introducer came apart after a cholangiogram was completed. The surgeon removed pieces of the taut introducer. The remainder of the cholecystectomy was completed without any further problems. Patient went to recovery in stable condition. No untoward patient effect.
Patient Sequence No: 1, Text Type: D, B5
[73846921]
(b)(4). Per dhr the product taut introducers 10/bx7. 5 fr x 3. 5, lot # 73j1600710 was manufactured on 10/03/2016 a total of (b)(4) pieces. Lot was released on 10/06/2016. Dhr investigation did not show issues related to complaint. Corrective actions cannot be established since it is necessary to receive the physical sample to perform a proper investigation and confirm the alleged defect. At this time due the sample is not available is not possible to determine the source of the defect reported. Customer complaint cannot be confirmed due the product sample is not available to perform a proper investigation and determinate the root cause. If the alleged defect samples become available at a later date, this complaint will be updated accordingly.
Patient Sequence No: 1, Text Type: N, H10
[73846922]
The inner lining of a taut introducer came apart after a cholangiogram was completed. The surgeon removed pieces of the taut introducer. The remainder of the cholecystectomy was completed without any further problems. Patient went to recovery in stable condition. No untoward patient effect.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3003898360-2017-00170 |
| MDR Report Key | 6417034 |
| Date Received | 2017-03-20 |
| Date of Report | 2017-02-21 |
| Date of Event | 2017-02-08 |
| Date Mfgr Received | 2017-02-28 |
| Device Manufacturer Date | 2016-09-27 |
| Date Added to Maude | 2017-03-20 |
| 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 | 3 |
| Brand Name | TAUT INTRADUCERS 10/BX7.5 FR X 3.5 |
| Generic Name | CATHETER, PERITONEAL |
| Product Code | GBW |
| Date Received | 2017-03-20 |
| Catalog Number | PI-93 |
| Lot Number | 73J1600710 |
| Device Expiration Date | 2019-09-06 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| 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 | 1. Required No Informationntervention | 2017-03-20 |