MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. FIRST PICC 26GA, SINGLE LUMEN

Catalog Number 384232

Device Problem Break (1069)

Patient Problems Discomfort (2330); Blood Loss (2597)

Event Date 02/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device history record was reviewed, and no similar concerns were found.A review of the returned product was performed.Visual inspection found that the picc tubing is broken approximately 1cm from the hub.The exact root cause is unable to be determined; however, a possible cause of the catheter breakage may be related to excessive tensile/pulling force during use.There were no issues identified related to manufacture of the product.All catheters undergo (100%) inspection during manufacturing.Catheters undergo tensile strength testing, flow, leak, and burst testing to ensure the integrity of the catheter and its ability to endure use.

Event Description

Nicu nurse responded to crying premature infant.Picc found lying in crib.Picc was broken at the oval section.Remainder of picc was still secured.Minimal bleeding at insertion site.Picc removed.No untoward patient effect.

• Brand Name: FIRST PICC 26GA, SINGLE LUMEN
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• Manufacturer (Section G): ARGON MEDICAL DEVICES INC.
• Manufacturer Contact: gail smith ; 1445 flat creek road; athens, TX 75751 ; 2144368995
• MDR Report Key: 8525025
• MDR Text Key: 142506312
• Report Number: 1625425-2019-00070
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,03/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/16/2021
• Device Catalogue Number: 384232
• Device Lot Number: 11225121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/08/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 03/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 14 DA