MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L 20GA (3F) 0.95MM X 65CM

Model Number	384156
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	10/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The sample is indicated as unavailable for evaluation.However, a image in-vivo has been provided.The review is in progress and a follow-up report will be provided once completed.
Event or Problem Description
Declaration issued by a doctor from the pediatric intensive care unit concerning the attachment of the integrated guidewire, causing an intravascular loop and the needs for remobilization of the catheter after closing the dressing the doctor mentions the occurrence of several incidents of this type with this model (the guidewire hangs when adjusting the length and /or withdrawing the guidewire ager installation) without further details.Last incident with the same model occurred on (b)(6) 2020 followed by a malfunction of the kt leading to its removal.There is no clinical consequence for the patient.Recurring problem with this model (different lots).
Additional Manufacturer Narrative
H3 other text : placeholder.
Event or Problem Description
Follow up.

• Brand Name: FIRST PICC S/L 20GA (3F) 0.95MM X 65CM
• Common Device Name: FIRST PICC
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX
• MDR Report Key: 10772927
• Report Number: 1625425-2020-00700
• Device Sequence Number: 19867245
• Product Code: FOZ
• UDI-Device Identifier: 00886333209675
• UDI-Public: 00886333209675
• Combination Product (Y/N): N
• PMA/510(K) Number: K972262
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Pharmacist
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2020

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
• Operator of Device: Health Professional
• Device Model Number: 384156
• Device Catalogue Number: 384156
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/02/2020
• Supplement Report FDA Received Date: 11/20/2020
• 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