MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH PICC KIT; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30

Catalog Number 384061

Device Problem Mechanics Altered (2984)

Patient Problem Venipuncture (2129)

Event Date 08/22/2014

Event Type  malfunction  

Event Description

Nurse obtained a picc kit.The nurse placed a picc and was able to thread it easily.Once the needle was withdrawn to peel away, it did not snap apart correctly.The nurse needed to use a hemostat to manipulate the needle and plastic wings to remove them.In doing so, the picc was compromised and needed to be removed.The patient required another stick.This facility has had similar events on other patients with this product.Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line.There has been approximately one or more similar events per month with this device over the last several months.The manufacturer has been notified and product has been returned to them for testing.The cause of the problem remains unknown.Staff are following the manufacturer's instructions for use of this product.
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manufacturer response for picc needle, splitable needle introducer (per site reporter)
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the manufacturer has numerous reports of this occurring.A letter was sent that acknowledges the problem.

Event Description

Nurse obtained a picc kit.The nurse placed a picc and was able to thread it easily.Once the needle was withdrawn to peel away, it did not snap apart correctly.The nurse needed to use a hemastat to manipulate the needle and plastic wings to remove them.In doing so, the picc was compromised and needed to be removed.The patient required another stick.This facility has had similar events on other patients with this product.Staff inserting these lines are very familiar with the product & have extra training in the insertion of the line.There has been approximately one or more similar events per month with this device over the last several months.The manufacturer has been notified and product has been returned to them for testing.The cause of the problem remains unknown.Staff are following the manufacturer's instructions for use of this product.
=
manufacturer response for picc needle, splitable needle introducer (per site reporter)
=
the manufacturer has numerous reports of this occurring.A letter was sent that acknowledges the problem.

• Brand Name: L-CATH PICC KIT
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 4091289
• MDR Text Key: 21719882
• Report Number: 4091289
• Device Sequence Number: 1
• Product Code: LJS
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Type of Report: Initial
• Report Date: 09/03/2014

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: Nurse
• Device Catalogue Number: 384061
• Device Lot Number: 11068425
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/03/2014
• Event Location: Hospital
• Date Report to Manufacturer: 09/16/2014
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/03/2014
• Patient Sequence Number: 1