GOLD 2WAY SIL 5CC 14FR 180705140

MAUDE Adverse Event Report

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.

Event Text Entries

[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


MAUDE Entry Details

Report Number8040412-2015-00168
MDR Report Key4973619
Report Source01,05,06,07,COMPANY REPRESENT
Date Received2015-08-05
Date of Report2015-07-13
Date of Event2015-01-01
Date Mfgr Received2015-11-23
Date Added to Maude2015-08-05
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactJASMINE BROWN
Manufacturer Street3015 CARRINGTON MILL BLVD
Manufacturer CityMORRISVILLE NC 27560
Manufacturer CountryUS
Manufacturer Postal27560
Manufacturer Phone9193614124
Manufacturer G1TELEFLEX MEDICAL
Manufacturer StreetPO BOX 28, KAMUNTING INDUSTRIAL ESTATE
Manufacturer CityPERAK, WEST MALAYSIA 34600
Manufacturer CountryMY
Manufacturer Postal Code34600
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameGOLD 2WAY SIL 5CC 14FR
Generic NameFOLEY CATHETER
Product CodeFGH
Date Received2015-08-05
Returned To Mfg2015-10-19
Catalog Number180705140
Lot Number14I139
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2015-08-05

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