MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM

Model Number	384467
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2022
Type of Reportable Event	Malfunction
Event or Problem Description
During safety check rn noted wetness at picc site.Rn attempted line and nad change to see if leaking would stop.Leaking continued picc team notified rn flushed and clamped picc line and noted crack in both lumens.Pge drip transitioned to piv and picc removed.Picc line saved.New picc line placed.Blue icu medical inc.Clave neutral connector attached to both lumens when leak found.Affect on patient: no harm to patient, event occur while in use with a patient.
Additional Manufacturer Narrative
The sample is indicated as available for return.As of the date of this report, the sample has not been returned.A follow-up report will be provided once the device has been received and reviewed.
Additional Manufacturer Narrative
The sample is indicated as returned.As of the date of this report, the sample has not been evaluated.A follow-up report will be provided once the device has been reviewed.
Event or Problem Description
During safety check rn noted wetness at picc site.Rn attempted line and nad change to see if leaking would stop.Leaking continued picc team notified rn flushed and clamped picc line and noted crack in both lumens.Pge drip transitioned to piv and picc removed.Picc line saved.New picc line placed.Blue icu medical inc.Clave neutral connector attached to both lumens when leak found.Affect on patient: no harm to patient, event occur while in use with a patient.
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.One opened catheter was returned for review.Visual inspection confirmed signs of use with the presence of dried fluids on the product.The red lumen luer was observed to be broken at an angle with part of the luer missing.The blue lumen luer was confirmed to have a crack which would result in leakage.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage.Capa 2021-039 was initiated to address this issue and is currently in the implementation phase.The capa will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.
Event or Problem Description
During safety check rn noted wetness at picc site.Rn attempted line and nad change to see if leaking would stop.Leaking continued picc team notified rn flushed and clamped picc line and noted crack in both lumens.Pge drip transitioned to piv and picc removed.Picc line saved.New picc line placed.Blue icu medical inc.Clave neutral connector attached to both lumens when leak found.Affect on patient: no harm to patient, event occur while in use with a patient.

• Brand Name: L-CATH PICC D/L 18GA (3.5F) 1.20MM X 60CM
• Common Device Name: L-CATH 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: 14744800
• Report Number: 0001625425-2022-01031
• Device Sequence Number: 14041199
• Product Code: FOZ
• UDI-Device Identifier: 00886333209866
• UDI-Public: 00886333209866
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K091670
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/15/2022

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 Model Number: 384467
• Device Catalogue Number: 384467
• Device Lot Number: 1402259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2022
• Supplement Date Received by Manufacturer: 06/14/2022; 06/14/2022
• Initial Report FDA Received Date: 06/20/2022
• Supplement Report FDA Received Date: 07/21/2022; 08/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown