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

Catalog Number 170605-000120

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/18/2020

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

Customer reported that the incident occurred on (b)(6) 2020 on ward 230p in the pulmonary clinic evangelischen lungenklinik buch.The patient was mobilized.The catheter was blocked in the urethra.The thin silicone catheter shaft came off the funnel.The thin silicone catheter shaft could still be removed.Under certain circumstances, however, the tube could have slipped completely into the urethra or bladder.The patient was not injured.Translation of event description in user report: the patient was mobilized out of bed and should be placed in a chair.The catheter was in the urethra / bladder inflated.When the patient stood up, no attention was paid to the fact that the urine bag was still attached to the opposite side of the bed.Thus, there was a strong pull on the catheter and the silicone shaft came off the funnel.However, the silicone shaft remained in the patient's urethra.The patient was not injured.The silicone shaft was then removed manually.Afterwards, we concerned that the silicone shaft could have been completely entered into the patient's urethra or bladder.

Event Description

Customer reported that the incident occurred on (b)(6) 2020 on ward 230p in the (b)(6) clinic (b)(6).The patient was mobilized.The catheter was blocked in the urethra.The thin silicone catheter shaft came off the funnel.The thin silicone catheter shaft could still be removed.Under certain circumstances, however, the tube could have slipped completely into the urethra or bladder.The patient was not injured.Translation of event description in user report: the patient was mobilized out of bed and should be placed in a chair.The catheter was in the urethra / bladder inflated.When the patient stood up, no attention was paid to the fact that the urine bag was still attached to the opposite side of the bed.Thus, there was a strong pull on the catheter and the silicone shaft came off the funnel.However, the silicone shaft remained in the patient's urethra.The patient was not injured.The silicone shaft was then removed manually.Afterwards, we concerned that the silicone shaft could have been completely entered into the patient's urethra or bladder.

Manufacturer Narrative

(b)(4).The batch card(s) for the complaint lot(s) was reviewed and passed all qa inspections.2 actual samples were returned for investigation.Visual inspection showed the funnels snapped from the shafts.Close review of the funnel section some portion of shaft with approximately 15mm long still intact inside the funnel lumens suggesting that the shafts were once attached to the funnels.Catheter broke may occur due to various reasons such as catheter was in contact with sharp or pointed object, effect of used of clamper , excessive force app lied at the funnel end or between the shaft as a result of catheter stuck at crib rail or tube extended as the patient glide on the bed.In addition, such phenomena of funnel detached from its shaft is likely to indicates rough or extreme force applied to the catheter which had caused shaft to snap.Such extreme tensile strength may exceed the standard requirement of the catheter strength which rendered the catheter to be detached or broke.Nevertheless, as part of our initiative, we have implemented positive released test at injection molding process.As per (b)(4), maximum of 8 pieces of catheter from each batch were tested using weight load test during start and stop of injection molding process whereby 0.75kg (for catheter size 6ch-10ch) and lkg load (for size 12ch and above) 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 found in the investigation, suggesting that the shafts were once well attached to the funnels.Besides that, the catheter likely been subjected to excessive force which caused catheter to break.Therefore, this complaint could not be confirmed.

• Brand Name: BRILLANT 2-W SILICONE FOLEY, CYLINDRICAL
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 10700443
• MDR Text Key: 214775136
• Report Number: 8040412-2020-00210
• 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: 09/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/19/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Date Manufacturer Received: 11/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1