MAUDE Adverse Event Report: TELEFLEX MEDICAL BRILLANT 100% SIL FOLEY 12FR

Catalog Number 170605-000120

Device Problem Break (1069)

Patient Problems Pain (1994); Abdominal Cramps (2543)

Event Date 07/04/2018

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 in the last 5 days the device had to be changed 3 times, because the shaft came off the junction.No force was applied on the catheters.Thus, the catheters balloon was no longer inflated and slipped out of the abdominal wall.A change of the catheter is always painful for the patient.The bladder is now very irritated and there are severe bladder cramps.When the device came out the third time, there were no available catheters in the home, so the patient had to be transported by ambulance to the urologist at the nearest hospital for device replacement.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed all samples passed qa inspection.The returned sample was carefully removed from the polybag and was subjected for visual inspection.First piece of the returned sample was identified to be only the funnel part.The second piece sample is a complete catheter (with adhesive tapes wrap around the funnel joint area) attached to a urine bag.The adhesive tape was carefully removed from the funnel joint area reveals that the funnel was completely detached from the rest of the 2nd piece in an equivalent manner of that 1st piece sample.Both funnel parts of the samples were examined and no traces of remaining parts of the shaft inside the funnel.This can be easily i dentified through the absence of the x-ray line traces inside the funnel.No remainings of the shaft were to be found inside both funnels.However, it was observed that there was presence of multiple scratches near the funnel joint area on both the funnel.No shaft remains inside both funnel.Multiple scratches found on the funnel near funnel joint.Investigation was then further conducted on the shaft where similar scratches appear at the shaft end.Funnel detachment 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 stenciled strength may exceed the standard requirement of catheter strength and render to catheter to be detached or break.Based on the above findings, we did not find any problem within the product which could have contributed from manufacturing processes.Therefore, we could not confirm the complaint as stated above.

Event Description

It was reported that in the last 5 days the device had to be changed 3 times, because the shaft came off the junction.No force was applied on the catheters.Thus, the catheters balloon was no longer inflated and slipped out of the abdominal wall.A change of the catheter is always painful for the patient.The bladder is now very irritated and there are severe bladder cramps.When the device came out the third time there were no available catheters in the home, so the patient had to be transported by ambulance to the urologist at the nearest hospital for device replacement.

• Brand Name: BRILLANT 100% SIL FOLEY 12FR
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• MDR Report Key: 7710903
• MDR Text Key: 114945346
• Report Number: 8040412-2018-00189
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/05/2018

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: 170605-000120
• Device Lot Number: 17BE08
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/05/2018
• Initial Date FDA Received: 07/23/2018
• Supplement Dates Manufacturer Received: 09/21/2018
• Supplement Dates FDA Received: 09/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1