MAUDE Adverse Event Report: TELEFLEX MEDICAL 100%SILICONE 2WAY PED 3 CC; FOLEY CATHETER

Catalog Number 170003100

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/13/2015

Event Type  malfunction  

Event Description

Alleged event: the catheter was inserted preoperatively and was later found severed or broken at the y junction.The patient's condition was reported as fine.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The device lot number was not provided; therefore a dhr review could not be conducted.Visual examination was conducted on the returned sample and it was observed that the catheter was broken into two parts; one on shaft and the funnel.The returned sample was realigned and measured on the length of it using a calibrated ruler.It was observed that the overall length met the specification of this product.Then, both the catheter shaft and funnel were examined using the dino-lite to analyze the damaged area.Based on the observation the torn edges were jagged where more material was seen on one side of the catheter.Visual examination on the other areas of the catheter shaft did not reveal any sign of abrasion mark or scratch.There is no trace of nick or scratches on the embedded shaft.Based on the investigation conducted, the catheter was found to be broken.No other related issue within the manufacturing processes that could lead to defective product.Therefore this complaint could not be confirmed.

Event Description

Alleged event: the catheter was inserted preoperatively and was later found severed or broken at the y junction.The patient's condition was reported as fine.

• Brand Name: 100%SILICONE 2WAY PED 3 CC
• Type of Device: FOLEY CATHETER
• Manufacturer (Section D): TELEFLEX MEDICAL; perak, west malaysia
• Manufacturer (Section G): TELEFLEX MEDICAL; po box 28, kamunting industrial estate; perak, west malaysia 3460 0; MY 34600
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 4913107
• MDR Text Key: 15907199
• Report Number: 8040412-2015-00158
• Device Sequence Number: 1
• Product Code: FGH
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 170003100
• 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: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Patient Sequence Number: 1