MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. L-CATH 26G (1.9F)0.60MM X 30CM; L-CATH PICC

Catalog Number 384539

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem Vomiting (2144)

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation and no images or videos have been provided, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

Event Description

User placed this line in a (b)(6)-day old patient who needed it for long term antibiotics.The first incident, the line ¿fell¿ out of patient according to father of child.This had never happened before, so user believed that it may have been accidentally pulled out when dad reached for baby while she was vomiting.The next day, user placed the line again and 9 hours later, user noticed the line had actually slipped out 2cm through the plastic purple hub.User thought they had fixed the issue by securing the line where it was at.However, this morning user was made aware that the line actually snapped over weekend from hub and it was fortunately found quickly to prevent it from migrating into patient.

• Brand Name: L-CATH 26G (1.9F)0.60MM X 30CM
• Type of Device: L-CATH 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: 9187463
• MDR Text Key: 169238794
• Report Number: 1625425-2019-00268
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/01/2005,09/18/2019

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: Health Professional
• Device Expiration Date: 05/08/2022
• Device Catalogue Number: 384539
• Device Lot Number: 11258658
• Was Device Available for Evaluation?: No
• 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
• Initial Date Manufacturer Received: 09/18/2019
• Initial Date FDA Received: 10/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 11 DA