MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 28GA (1.2F) 0.40MM X 25CM

Model Number 384540

Device Problem Crack (1135)

Patient Problem Insufficient Information (4580)

Event Date 06/06/2023

Event Type  malfunction  

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 Description

Date of event:(b)(6) 2023.Picc insertion date: (b)(6) 2023.Description of event:¿hub cracked during fluid tubing change¿ ¿picc adapter noted to be leaking.Picc removed be edna (charge) and will attempt another picc line insertion.Piv started fir iv fluids for the mean time, (b)(6) (nnp) made aware¿ any patient harm? ¿lbw infant no longer with central line access.¿ was a new piv placed to complete prescribed therapy ¿yes¿ was a new picc placed to complete prescribed therapy ¿no.No vein access available for picc.¿.

Event Description

Date of event: 6/6/2023; picc insertion date: (b)(6) 2023.Description of event:¿hub cracked during fluid tubing change¿ ¿picc adapter noted to be leaking.Picc removed be edna (charge) and will attempt another picc line insertion.Piv started fir iv fluids for the mean time, (b)(6) made aware.¿ any patient harm? ¿lbw infant no longer with central line access.¿ was a new piv placed to complete prescribed therapy ¿yes.¿ was a new picc placed to complete prescribed therapy ¿no.No vein access available for picc.¿.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.After three notifications, there has been no sample returned.Additionally, there has been no visual evidence provided to support the reported issue.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.

• Brand Name: L-CATH PICC S/L 28GA (1.2F) 0.40MM X 25CM
• Type of Device: 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: 17305654
• MDR Text Key: 319663107
• Report Number: 0001625425-2023-01114
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K091670
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/28/2023

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 Model Number: 384540
• Device Lot Number: 11394106
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/30/2023
• Initial Date FDA Received: 07/12/2023
• Supplement Dates Manufacturer Received: 06/30/2023
• Supplement Dates FDA Received: 11/28/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other