MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional report with the FDA on 2020-03-19 for GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC 180003-000080 manufactured by Teleflex Medical Sdn. Bhd..
[186332928]
(b)(4). 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
[186332929]
Customer reported that patients condition were both diagnosed with acute renal failure (due to hypovolemic shock and the other one septic shock). The medical staff would want to monitor the urine output strictly which led to the decision to insert the catheter. Before catheter insertion, urine was passing with very minimal unquantified amount. Then upon inserting the catheter, there was no urine passage to the bag, or any leakage noted. Catheter remained inserted for 4-6 hours in the patient without any output. As soon the catheter was removed, both patients immediately passed urine. We decided to not insert the catheter anymore on both case and used alternative methods (diaper weighing and placement of clean gloves for the male patient). Both incidents had the same issue not able to pass urine since the catheter was inserted then upon trying to remove it the port failed to deflate the balloon. Precipitation in the tube and obstruction, which prevents passing the fluids through it. The extraction/removal of fluid in the balloon fails in the port.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2020-00096 |
| MDR Report Key | 9855885 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL |
| Date Received | 2020-03-19 |
| Date of Report | 2020-03-09 |
| Date of Event | 2019-08-22 |
| Date Mfgr Received | 2020-03-09 |
| Date Added to Maude | 2020-03-19 |
| 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 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 | GOLD LATEX FOLEY, CYLINDRICAL,PAEDIATRIC |
| Product Code | EZL |
| Date Received | 2020-03-19 |
| Catalog Number | 180003-000080 |
| Lot Number | 15B04 |
| Device Expiration Date | 2020-01-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| 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 | 1. Required No Informationntervention | 2020-03-19 |