MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM

Model Number	384101
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Sample is unavailable for evaluation.Videos were provided for analysis.A follow-up will be submitted after videos are analyzed and reviewed.
Event or Problem Description
On june 8th , a picc catheter was inserted in a child admitted to the pediatric intensive care unit, the catheter was lubricated according to routine, the mandrel was pulled 3cm for introduction, the catheter progressed easily, with good flow and reflux, however, at the moment of total traction of the mandrel, it did not come out, getting stuck to the catheter, collapsed, bringing the catheter out.When forcing the withdrawal, it ended up damaging it.This happened with two catheters in the same patient.Due to the need of access, a third catheter was necessary, in which i removed the mandrel before inserting it, to obtain success in the procedure.I take the opportunity to register that this same episode has already happened in the passage of picc catheter in adults, with me and with my colleagues.
Event or Problem Description
On (b)(6) , a picc catheter was inserted in a child admitted to the pediatric intensive care unit, the catheter was lubricated according to routine, the mandrel was pulled 3cm for introduction, the catheter progressed easily, with good flow and reflux, however, at the moment of total traction of the mandrel, it did not come out, getting stuck to the catheter, collapsed, bringing the catheter out.When forcing the withdrawal, it ended up damaging it.This happened with two catheters in the same patient.Due to the need of access, a third catheter was necessary, in which i removed the mandrel before inserting it, to obtain success in the procedure.I take the opportunity to register that this same episode has already happened in the passage of picc catheter in adults, with me and with my colleagues.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.There was no sample available for review, however, a video of the reported issue was provided.Based on the review of the video, the resistance was confirmed.Without the sample to review, determining a definite root cause for the resistance is not possible.There have been no other complaints regarding this issue with this lot number.Since a definite root cause could not be established and there have been no other complaints regarding this issue with this lot number, no corrective action will be taken at this time.Argon will continue to monitor for issues of this nature in the future.

• Brand Name: FIRST PICC S/L 22GA (2.8F) 0.95MM X 50CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: elnaz rahman ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 15191881
• Report Number: 0001625425-2022-01058
• Device Sequence Number: 12225180
• Product Code: FOZ
• UDI-Device Identifier: 00886333209644
• UDI-Public: 00886333209644
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/30/2024
• Device Model Number: 384101
• Device Catalogue Number: 384101
• Device Lot Number: 11388767
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/09/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Sex: Unknown