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

Model Number	384463
Medical Device Problem Codes	Break (1069); Crack (1135)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
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.
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).
Additional Manufacturer Narrative
A review of the dhr and inspection records was conducted, and no similar concerns were found.Two catheters were returned for review.They were marked for both this complaint and for cc 19239.It could not be determined which returned catheter belonged to this complaint.Both catheters were visually inspected by the analyst along with the area supervisor and both catheters exhibited signs of use.Breakage of the catheter was confirmed in both returned catheters.One of the catheters was observed to have two breakage areas, one at the base of the luer and the other approximately 3.5 cm below the strain relief.The breakage area was examined under a microscope and it was observed that the edges were jagged and discolored which is indicative of a tensile force applied to the catheter.The most probable cause for the breakage was most likely due to an event within the user environment.Possibly patient movement or mishandling of the catheter resulted in the breakage.Since the reported issue was most likely related to an event within the user environment and not a manufacturing error, no corrective action will be taken at this time.Argon will continue to monitor for this issue in the future.
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: 17425646
• Report Number: 0001625425-2023-01151
• Device Sequence Number: 7571584
• Product Code: LJS
• UDI-Device Identifier: 00886333209828
• UDI-Public: 00886333209828
• Combination Product (Y/N): N
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/29/2023

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?: Device Returned to Manufacturer
• 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
• Supplement Date Received by Manufacturer: 07/06/2023
• Initial Report FDA Received Date: 07/31/2023
• Supplement Report FDA Received Date: 08/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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