MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2015-06-04 for RUSCH 100%SILICONE 2WAY 5CC 16FR 170605160 manufactured by Teleflex Medical.
[5841492]
The hosp reported the following incident: the catheter was inserted by the nurse and the balloon was inflated with 10ml of sterile water. Many hours later, the nurse found the balloon split, and as a result the catheter had to be replaced. There were no clinical consequences for the pt as a result of the incident, and hospitalization was not prolonged as a result of it either. No pt injury reported.
Patient Sequence No: 1, Text Type: D, B5
[13506220]
Qn # (b)(4). The device sample was not received by the manufacturer at the time of this report. See scanned page.
Patient Sequence No: 1, Text Type: N, H10
[25527367]
(b)(4). The device history record was reviewed and no issue that could have contributed to the reported failure was noted. The device was manufactured according to release specification. The returned sample was carefully removed from polybag and visually inspected. The sample appeared to be in good condition except that the balloon was split. Closer examination on the split balloon area under dino -lite, a high magnification microscope (20x magnification) revealed scratch marks near the tear region. In our standard operating procedure the raw balloons are subjected to 100% visual inspection using magnification lens. Defective raw balloon will be culled out before sent to the next process, then tested for leaks in the catheter system. Products that pass this test will be subjected to the next process. Based on the investigation and testing conducted on the actual sample, the split balloon root cause could not be identified. Therefore, we could not confirm this complaint as stated.
Patient Sequence No: 1, Text Type: N, H10
[25527548]
The hospital reported the following incident: the catheter was inserted by the nurse and the balloon was inflated with 10ml of sterile water. Many hours later the nurse found the balloon split, and as a result the catheter had to be replaced. There were no clinical consequences for the patient as a result of the incident, and hospitalization was not prolonged as a result of it either. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 8040412-2015-00125 |
| MDR Report Key | 4820864 |
| Report Source | 01,05,06 |
| Date Received | 2015-06-04 |
| Date of Report | 2015-05-13 |
| Date of Event | 2015-05-01 |
| Date Mfgr Received | 2015-07-02 |
| Date Added to Maude | 2015-07-02 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| 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 | PO BOX 28, KAMUNTING INDUSTRIAL ESTATE P.O. BOX 28 |
| 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 | RUSCH 100%SILICONE 2WAY 5CC 16FR |
| Generic Name | FOLEY CATHETER |
| Product Code | FGH |
| Date Received | 2015-06-04 |
| Returned To Mfg | 2015-06-15 |
| Catalog Number | 170605160 |
| Lot Number | 14JE42 |
| Device Expiration Date | 2019-09-30 |
| 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 | PERAK, WEST MALAYSIA MY |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-06-04 |