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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARGON MEDICAL DEVICES, INC. L-CATH PICC D/L 2.6F 60CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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ARGON MEDICAL DEVICES, INC. L-CATH PICC D/L 2.6F 60CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 384466A
Device Problems Crack (1135); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2023
Event Type  malfunction  
Event Description
Rn noted fluid/wetness when checking lines.Small amount of fluid noted at junction of peripherally inserted central catheter (picc) hub and extension set.Uncertain etiology so advised rn to perform a sterile cap/extension set change to determine if the cause was from the extension set or the actual picc.Upon disconnecting extension set, it was found that the actual hub on the picc line was cracked and causing the leaking.
 
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Brand Name
L-CATH PICC D/L 2.6F 60CM
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
ARGON MEDICAL DEVICES, INC.
1445 flat creek rd
athens TX 75751
MDR Report Key16409254
MDR Text Key309888193
Report Number16409254
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/15/2023
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 Catalogue Number384466A
Device Lot Number11456642
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/15/2023
Event Location Hospital
Date Report to Manufacturer02/21/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/21/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age12 DA
Patient SexMale
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