MAUDE Adverse Event Report: TELEFLEX MEDICAL 100% SIL TIEMANN 2WAY 5CC

Catalog Number 171305160

Device Problem Torn Material (3024)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device sample has been returned to the manufacturer but the investigation report has not been submitted at the time of this report.The manufacturer will continue to monitor and trend related events.

Event Description

Alleged event: the balloon was reported to be torn.The catheter was being used on the patient for urinary drainage.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).The device history record was reviewed and no issue that could have contributed to the reported failure was noted.The device was manufactured according to release specification.The sample appeared to be in a good condition except that the balloon was split.Closer examination on the split balloon area under dino-lite revealed scratch marks near the tear region.In our standard operating procedure, the raw balloons are subjected to 100% visual inspection using magnification lens.Defective raw balloon will be culled out before sent to the next process.After assembly, all foley catheters are then subjected to leak test.Product that passed this test will be subjected to the next process.Based on the investigation conducted on the actual sample, it is believed that the scratch marks found near the split area had initiated the tear.Therefore, we could not confirm this complaint as stated.

Event Description

Alleged event: the balloon was reported to be torn.The catheter was being used on the patient for urinary drainage.The patient's condition was reported as fine.

• Brand Name: 100% SIL TIEMANN 2WAY 5CC
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 34600 ; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 5005467
• MDR Text Key: 24295295
• Report Number: 8040412-2015-00173
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Nurse
• Report Date: 07/20/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 171305160
• Device Lot Number: 14KE46
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2015
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1