Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TELEFLEX MEDICAL SDN. BHD. BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC Back to Search Results
Catalog Number 170003-000080
Device Problem No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/15/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The catheter was inserted in the neuro-surgery department on (b)(6) 2021.Staff observed when they took care of the patient in intensive care that there was an issue with the device.The catheter was blocked.Decision was made to change the device.When changing the catheter, the staff observed it was impossible to deflate the balloon.Clinical consequences: the patient had distended bladder.He had small lesions of the urethra after removal.Bleeding for a few days due to the inability to deflate the balloon and having removed the balloon inflated.Now patient is out of the department and users stated it's all fine now.
 
Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed and all passed qa inspection.One piece of actual sample was returned for investigation.However , only part of the catheter shaft was received.Based on the complaint statement, it was reported that there was an issue with the catheter since it seemed blocked and when changing the catheter, the staff observed it was impossible to deflate the balloon.Examination on the returned part observed that there is no sign of blockage at the drainage eye of the catheter (refer picture 1).However , further investigation could not be conducted to identify the actual problem since the sample returned was incomplete.To verify the accessibility to the balloon deflation, the actual sample was inflated with 5ml of water using venflon needle showed no issue to stay inflate.The sample was then subjected to deflation testing using the same method.Once again, the sample was able to deflate completely without having any difficulty.Non-deflation could be due to several reasons such as improper fixation of syringe to the valve, faulty valve and blockage of inflation lumen.In a standard practice, an empty syringe without plunger is also recommended to be used to drain off the fluid by gravity and avoid creation of vacuum effect and ease deflation process.Besides that , based on the ifu, it was advised to cut the shaft near the entry site as to allow the liquid to flow out of the balloon if the valve fails to deflate the balloon.In current standard operating procedure, the product will undergo several stages of inspection.Water leak test was performed after funnel injection molding process as per spm-a51-002.Defective catheter (such as blocked) will be detected and culled out during this process.Final 100% visual inspection and leak test are also conducted on the catheter as per spm-a52-004 and product will be released upon passing this inspection.Besides that, the balloons are subjected to 100% visual inspection as per spm-a51-003, and any defective raw balloon will be discarded before sent to the next process.Upon completion of assembly process , the finished catheter will be again subjected to 100% balloon inspection, 20 minutes leak test and 100% deflation process (spm-a52- 004).Catheter with defective balloon will be culled out during this process.Blockage or non-deflation balloon may due to several reasons.However, no sign of blockage observed at the drainage eye of the catheter and no deflation issue encountered on the catheter part received.Since the catheter returned was incomplete, further investigation could not be conducted to identify the actual problem.Therefore, this complaint could not be confirmed.
 
Event Description
The catheter was inserted in the neuro-surgery department on (b)(6) 2021.Staff observed when they took care of the patient in intensive care that there was an issue with the device.The catheter was blocked.Decision was made to change the device.When changing the catheter, the staff observed it was impossible to deflate the balloon.Clinical consequences: the patient had distended bladder.He had small lesions of the urethra after removal.Bleeding for a few days due to the inability to deflate the balloon and having removed the balloon inflated.Now patient is out of the department and users stated it's all fine now.
 
Manufacturer Narrative
(b)(4).The batch card(s) for the complaint lot(s) was reviewed 100% visual inspection was conducted, and no abnormalities found.No sample was returned for investigation; therefore, no physical investigation could be conducted.Conclusion : balloon could not be deflated may be due to several reasons.Due to there was no actual sample returned for this complaint, any further investigation was not possible.Thus, th is complaint cannot be confirmed.
 
Event Description
The catheter was inserted in the neuro-surgery department on (b)(6) 2021.Staff observed when they took care of the patient in intensive care that there was an issue with the device.The catheter was blocked.Decision was made to change the device.When changing the catheter, the staff observed it was impossible to deflate the balloon.Clinical consequences: the patient had distended bladder.He had small lesions of the urethra after removal.Bleeding for a few days due to the inability to deflate the balloon and having removed the balloon inflated.Now patient is out of the department and users stated it's all fine now.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BRILLANT SILICONE FOLEY, CYL. PAEDIATRIC
Manufacturer (Section D)
TELEFLEX MEDICAL SDN. BHD.
perak, west malaysia
MDR Report Key11686343
MDR Text Key249308176
Report Number8040412-2021-00105
Device Sequence Number1
Product Code EZL
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup,Followup
Report Date 03/30/2021
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 Catalogue Number170003-000080
Device Lot Number19GE28
Was Device Available for Evaluation? Yes
Initial Date Manufacturer Received 03/30/2021
Initial Date FDA Received04/19/2021
Supplement Dates Manufacturer Received05/11/2021
05/28/2021
Supplement Dates FDA Received05/24/2021
05/28/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-