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

Catalog Number 170605-000160

Device Problem Break (1069)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 06/08/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.

Event Description

The report states: catheters broke see picture sent with this case, broke in the smallest part, the catheter was only a few hours in situ; the balloon was filled with 10 cc water.They placed a new catheter after this one broke.A little bit of bleeding occurred.Additional information: there was barely any bleeding, a minimal amount; no intervention was required due to bleeding and bleeding stopped.

Manufacturer Narrative

(b)(4).Device history record batch card for the complaint lots were reviewed and passed the qa inspection.An actual sample and a representative sample were returned for investigation.It was reported that catheter broke.Visual inspection on the catheter did not show any obvious defects or abnormality.All components were intact and appeared to be in good condition.There was no sign of kinking, clamp mark or collapse lumen observed throughout the shaft.Further investigation, the samples were subjected to weight load test as per spm-a51-002.Lkg of load were attached to the sample and the catheter was hung for 1 minute.No sign of any funnel detachment and catheter broke were observed on the tested samples.Catheter broke may occur due to several 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 because of catheter stuck at crib rail or tube extended as the patient glide on the bed.Such extreme tensile strength may exceed the standard requirement of catheter strength and render catheter to be detached or break.Based on the investigation conducted on the both returned samples , no issue found within the products which could have contributed from manufacturing processes.Therefore, this complaint could not be confirmed.

Event Description

The report states: catheters broke see picture sent with this case, broke in the smallest part, the catheter was only a few hours in situ; the balloon was filled with 10 cc water.They placed a new catheter after this one broke.A little bit of bleeding occurred.Additional information: there was barely any bleeding, a minimal amount; no intervention was required due to bleeding and bleeding stopped.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10168429
• MDR Text Key: 196220332
• Report Number: 8040412-2020-00131
• 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: 06/09/2020

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 Number: 170605-000160
• Device Lot Number: 19KG15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/18/2020
• Initial Date Manufacturer Received: 06/09/2020
• Initial Date FDA Received: 06/18/2020
• Supplement Dates Manufacturer Received: 07/24/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1