MAUDE Adverse Event Report: COLOPLAST A/S FOLYSIL TIEMANN CATH 5; FOLEY CATHETER

Model Number AA63161000

Device Problem Burst Container or Vessel (1074)

Patient Problems Pain (1994); Distress (2329)

Event Date 05/13/2019

Event Type  malfunction  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, the nurse advised filling the balloon with 10cc of saline as per the package instructions and the balloon popped once inflated inside the patient.The instructions did say to test the balloon before insertion as a standard practice.It was reported that the balloon bursting incident caused the patient significant pain and distress and required the patient to travel to the emergency room to gain access to care to assess if any injury took place and then replace the catheter.The balloon was being filled to 15cc, and the balloon was not tested prior to insertion.The patient was switched to another product.

Manufacturer Narrative

This follow-up is created to document the conclusion of the investigation.The product reference aa63161002 has a balloon of 10ml.According the instruction for use inflating the balloon with sterile water to the volume indicated on the package label.13 similar cases were found for aa6316 since ce marking.Foley catheters are also widely used for the management of urinary retention or incontinence or following surgery.Catheterization is a standard surgical technique and management of the catheter maintenance depends on the health care practitioners.The choice of the size, balloon volume and material of catheter is under the responsibility of the healthcare professional based on the patient status and planned indwelling time.Long-term use of foley catheter may be associated with complications e.G.Urinary tract infection.Therefore, this type of medical device must only be used by trained and experienced professionals.The balloon burst issue is known and monitored on a monthly basis.Possible root cause is a weakness area in the silicone material of the balloon.Specific trends are monitored regarding the silicone balloon issue.Rmf identification was reviewed.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: FOLYSIL TIEMANN CATH 5
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, 3050 ; DA 3050
• MDR Report Key: 9644401
• MDR Text Key: 188933391
• Report Number: 9610711-2020-00002
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K013174
• 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: 03/19/2020

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: No Information
• Device Model Number: AA63161000
• Device Catalogue Number: AA6316
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/31/2019
• Initial Date FDA Received: 01/29/2020
• Supplement Dates Manufacturer Received: 12/31/2019
• Supplement Dates FDA Received: 03/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other