MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM

Model Number 384232

Device Problem Positioning Problem (3009)

Patient Problem Insufficient Information (4580)

Event Date 10/05/2020

Event Type  malfunction  

Manufacturer Narrative

The device is unavailable for evaluation.However, images were provided.Based on the review of the images, the space between the luer/hub and the actual picc could not be confirmed.If the picc line was not fully attached to the hub, the leak would have been found while flushing the device prior to use.Without the actual device used available for review, the root cause cannot be determined.

Event Description

The picc was inserted by nicu on (b)(6) 2020.Pt is now on a peds m/s unit.Nurse called to inform me that there is a space between the luer /hub, and the actual picc.Picc is indwelling in patient.Per nurse, discussion of alternative central access was discussed in rounds.

• Brand Name: FIRST PICC S/L 26GA (1.9F) 0.65MM X 50CM
• Type of Device: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• Manufacturer Contact: gina liu ; 1445 flat creek rd, athens, tx 75751
• MDR Report Key: 10727717
• MDR Text Key: 215093714
• Report Number: 1625425-2020-00696
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209750
• UDI-Public: 00886333209750
• Combination Product (y/n): N
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 10/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384232
• Device Catalogue Number: 384232
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other