MAUDE Adverse Event Report: TELEFLEX MEDICAL FOLYSIL SILICONE FOLEY CATHETER; CATHETER, RETENTION TYPE, BALL

Catalog Number 170605160

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem Pain (1994)

Event Date 09/12/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.

Event Description

Issue reported by customer: i purchased a box of 10 of all silicone foley catheters.They are inserted by a medical professional.The balloon is inflated using a 10 ml standard saline syringe.Two weeks into the use of this foley catheter, a small pinhole allowed the saline to leak out into the bladder and it was forced out by contraction at great pain.The balloon had part of a cc of saline still inside it.Upon inspection and re-inflation there are pinholes in the balloon area.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.One returned samples were carefully removed from polybag and visually inspected.Visual examination were conducted and observed that no abnormalities or design irregularities observed on returned samples.Based on complaint statement, it is likely that the balloon deflated after 2 week used because of a small pinhole on balloon.Further investigation was carried out by inflating the sample with air via an empty syringe was easy and smooth.However, balloon was not able to stay inflate.Closer examination under high magnification lens (50x magnifications) using dino-lite revealed the balloon have severe scratch marks found and multiple holes on the balloon surface.In our standard operating procedure, there are several stages of inspection carried out.The raw balloons were subjected to 100% visual inspection, defective raw balloon will be culled out before sent to the next process.Upon completion of assembly process, the finished catheter will be again subjected to the 1oo% balloon inspection and leak test whereby the inflated balloon will be left on a other remarks: leak test conveyor for approximately 20 minutes.Defective balloons will be culled out from the lot.Based on the investigation there is multiple scratch marks and holes found on the balloon sleeve which likely occurred due to contact with sharp or pointed objects, such as bladder/kidney stones and encrustation which causes leak to the balloon.Therefore this complaint is not confirmed.(b)(4).

Event Description

Issue reported by customer: i purchased a box of 10 of all silicone foley catheters.They are inserted by a medical professional.The balloon is inflated using a 10ml standard saline syringe.Two weeks into the use of this foley catheter, a small pinhole allowed the saline to leak out into the bladder and it was forced out by contraction at great pain.The balloon had part of a cc of saline still inside it.Upon inspection and re-inflation there are pinholes in the balloon area.

• Brand Name: FOLYSIL SILICONE FOLEY CATHETER
• Type of Device: CATHETER, RETENTION TYPE, BALL
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6910388
• MDR Text Key: 88022866
• Report Number: 8040412-2017-00213
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K972184
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 170605160
• Device Lot Number: 16IT09
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/12/2017
• Initial Date FDA Received: 10/03/2017
• Supplement Dates Manufacturer Received: 11/09/2017
• Supplement Dates FDA Received: 11/09/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1