MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL

Catalog Number 170605-000180

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2021

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

It was reported that the foley is fractured during in use.The broken part is at the red connector.

Event Description

It was reported that the foley is fractured during in use.The broken part is at the red connector.

Manufacturer Narrative

(b)(4), lot number provided was not found in the system under catalogue 170605-000180.An actual sample returned for investigation.It was reported that foley fracture during use.Visual examination was conducted on the returned sample and it was observed that the catheter was broken at 260mm measured from the tip of the catheter.The returned sample was realigned, and the total length was measured using a calibrated ruler.It was observed that the overall length was 395mm which still meets the specification (380mm-410mm) defined for this product.Closer examination was conducted to analyze the damaged area.Based on observation, the torn edges were likely clear-cut appearance which most likely indicating that there is probably the catheter has been contacted with sharp or pointed object and causing torn at the area.Torn shaft may occur due to various reasons such as catheter was in contact with sharp or pointed object, effect of used of clamper , excessive force applied at the funnel end or between the shaft as a results of catheter stuck at crib rail or tube extended as the patient glide on the bed.Nevertheless, as part of our initiative, positive released test was conducted at injection molding process.As per spm-asl-002 , maximum of (b)(4) pieces of catheter from each batch were tested using weight load during start and stop of injection molding process.0.75kg load (for catheter size ch6-ch10) and lkg load (for size ch12 and above) will be tested as per bs en is020696:2018 standard.This is to test the bonding strength between the funnel and tube.Batches that pass this test are subjected for release.Based on the evidence of clean cut observed on the sample, most probably the catheter had been contacted with sharp or pointed object which caused the catheter to be torn.Therefore, this complaint could not be confirmed as manufacturing related.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11342544
• MDR Text Key: 233788672
• Report Number: 8040412-2021-00043
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 170605-000180
• Device Lot Number: 19KG26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2021
• Date Manufacturer Received: 03/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1