MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 20GA (3F) 1.00MM X 60CM

Model Number	384463
Medical Device Problem Code	Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"a review of the dhr and inspection records was conducted, and no similar concerns were found.According to the product experience report there was no sample available for review.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, the results are inconclusive.However, based on the number of complaints regarding the same issue with this part number, this complaint will be confirmed.Several complaints for this part number have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 was initiated to address this issue.The capa is currently in the implementation phase and will evaluate the corrective action implementation for effectiveness to prevent a recurrence of this issue.".
Event or Problem Description
Broken catheter, this one cracking at the level of the plastic junction.For the moment our babies are doing well following the incidents.But from the perspective that our premature baby, who is basically a very fragile baby with no immune defence, each installation where the breakage of the catheters has occurred, which has required a 2nd or even a 3rd installation, is an injury which is difficult to justifiable and this poses several major risks to its follow-up.The damages are many.A delay in treatment (parenteral nutrition and antibiotics, hemodynamic instability) which is essential to its survival a potential risk of infection related to multiple catheter changes.A risk of deterioration of the state of health during intra-hospital transport.Pain related to the installation procedure.The risk of weight loss and hypoglycemia.A major source of stress for families.(french translated to english).

• Brand Name: L-CATH PICC S/L 20GA (3F) 1.00MM 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: 17424121
• Report Number: 0001625425-2023-01147
• Device Sequence Number: 15346436
• Product Code: LJS
• UDI-Device Identifier: 00886333209828
• UDI-Public: 00886333209828
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/31/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/06/2025
• Device Model Number: 384463
• Device Lot Number: 11438841
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/31/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2022
• 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
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown