TRANSURETHRAL CATHETER 170605-000160

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 2015-07-21 for TRANSURETHRAL CATHETER 170605-000160 manufactured by Teleflex Medical.

Event Text Entries

[15261838] Qn#(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


[15391489] Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5


[25531524] (b)(4). The device history record for lot 14ke45 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 100% visually inspected using magnification lens. The sample appeared to be in a good condition except that the balloon was split. Closer examination on the split balloon area under dino-lite revealed scratch marks near the tear region. Any defective raw balloon will be culled out before being sent to the next process. After assembly, all foley catheters are then subjected to leak test. Products that pass this test will be subjected to the next process. Based on the investigation conducted on the actual sample, it is believed that the scratch marks found near the split area had initiated the tear, due to contact with sharp or pointed object. Therefore, we could not confirm this complaint, as stated.
Patient Sequence No: 1, Text Type: N, H10


[25531525] Alleged event: the nurse inserted the catheter, when balloon was inflated, it snapped. The patient's condition was reported as fine.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number8040412-2015-00157
MDR Report Key4929649
Report Source01,05,06,07,COMPANY REPRESENT
Date Received2015-07-21
Date of Report2015-06-25
Date of Event2015-06-01
Date Mfgr Received2015-08-18
Date Added to Maude2015-07-21
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 NameTRANSURETHRAL CATHETER
Generic NameFOLEY CATHETER
Product CodeFGH
Date Received2015-07-21
Catalog Number170605-000160
Lot Number14KE45
OperatorHEALTH PROFESSIONAL
Device Availability*
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTELEFLEX MEDICAL
Manufacturer AddressPERAK, WEST MALAYSIA


Patients

Patient NumberTreatmentOutcomeDate
10 2015-07-21

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