MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07,company represent report with the FDA on 2015-08-05 for GOLD 2WAY SIL 5CC 14FR 180705140 manufactured by Teleflex Medical.
[16955039]
Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well. The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[17256205]
(b)(4). The device sample has not been returned to the manufacturer for investigation at the time of this report. The manufacturer will continue to monitor and trend related events.
Patient Sequence No: 1, Text Type: N, H10
[25528685]
(b)(4). The device lot number 141139 provided is not present in system, therefore a dhr review could not be conducted. There was no sample returned for investigation. Therefore; investigation was conducted based on current production samples. Catheters passed the requirements of the functionality test. Visual inspection conducted on the samples observed there was no burst or crack found on the balloons. Based on investigation conducted, production samples are fully functional. The balloons were able to inflate and deflate without any difficulties faced. Furthermore, the catheters have passed the soak test, which indicates no leak of water during catheterization. Then, the catheters also have passed reverse flow rate test, which indicates no blockage of the drainage lumen. No other abnormalities were observed. Therefore, this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[25528686]
Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well. The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
[32024470]
(b)(4). The device lot number that was provided by the customer is unknown; therefore, a dhr review could not be conducted. One actual complaint sample was returned for investigation. Visual examination was conducted and the catheter was unable to expand, because the balloon area was flattened, as it had been pressed with heavy object or due to excessive aspiration during catheter removal and manipulation. Reviewing the manufacturing process, no potential cause could have contributed to the problem. All products were subjected to 100% inspection of leak test, inflation, and deflation test. The defect related to functionality of the product will be culled out during inspection. Based on analysis conducted, the returned catheter could not inflate due to the balloon area indentation. Since there was no blockage issue observed based on reported failure, therefore; this complaint could not be confirmed.
Patient Sequence No: 1, Text Type: N, H10
[32024471]
Alleged event: the balloon failed to deflate when it was time to remove the catheter; cutting the shaft failed to work as well. The patient was repositioned and the catheter was manipulated until another staff member was able to aspirate enough water that the catheter was able to be removed. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5
Report Number | 8040412-2015-00168 |
MDR Report Key | 4973619 |
Report Source | 01,05,06,07,COMPANY REPRESENT |
Date Received | 2015-08-05 |
Date of Report | 2015-07-13 |
Date of Event | 2015-01-01 |
Date Mfgr Received | 2015-11-23 |
Date Added to Maude | 2015-08-05 |
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 | PO BOX 28, 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 2WAY SIL 5CC 14FR |
Generic Name | FOLEY CATHETER |
Product Code | FGH |
Date Received | 2015-08-05 |
Returned To Mfg | 2015-10-19 |
Catalog Number | 180705140 |
Lot Number | 14I139 |
Operator | HEALTH PROFESSIONAL |
Device Availability | R |
Device Age | DA |
Device Eval'ed by Mfgr | R |
Device Sequence No | 1 |
Device Event Key | 0 |
Manufacturer | TELEFLEX MEDICAL |
Manufacturer Address | PERAK, WEST MALAYSIA |
Patient Number | Treatment | Outcome | Date |
---|---|---|---|
1 | 0 | 2015-08-05 |