MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a distributor report with the FDA on 2020-03-27 for FLOCATH QUICK KIT - 16 F 221400160 manufactured by Teleflex Medical Sdn. Bhd..
[185253371]
(b)(4). There were 5 boxes with 100 items in each box.. The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[185253372]
It was reported that the insertion tray inside this kit is expired by 3 years. These were found upon receipt at a distributor's warehouse; they never reached a medical facility.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00107 |
| MDR Report Key | 9889412 |
| Report Source | DISTRIBUTOR |
| Date Received | 2020-03-27 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-03-05 |
| Date Mfgr Received | 2020-03-05 |
| Date Added to Maude | 2020-03-27 |
| 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 |
| Reporter Occupation | RISK MANAGER |
| 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 SDN. BHD. |
| Manufacturer Street | LOT NO : PT2577 JALEN PERUSAHAAN 4 KAMUNTING INDUSTRIAL ESTATE |
| Manufacturer City | PERAK, WEST MALAYSIA 34600 |
| Manufacturer Country | MY |
| Manufacturer Postal Code | 34600 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOCATH QUICK KIT - 16 F |
| Generic Name | CATHETER, URETHRAL |
| Product Code | GBM |
| Date Received | 2020-03-27 |
| Catalog Number | 221400160 |
| Lot Number | 10075113 |
| Device Expiration Date | 2017-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL SDN. BHD. |
| Manufacturer Address | PERAK, WEST MALAYSIA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-27 |