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 03/28/2022

Event Type  malfunction  

Event Description

Cracked hub.Insertion: (b)(6) 2022.After reviewing the records, each event occurred with or following a dressing change.According to the nurses, no excessive force was used during the connection of the smallbore extension set¨.In general, babies have been pricked more than once to obtain new venous access.No infection related to broken equipment.On (b)(6) 2022 the baby had an emergency picc re-insertion.This baby was very unstable, he was on dopamine and midazolan.A need for 100% fio2 during the re-insertion procedure.(weight 790g).

Manufacturer Narrative

Ta 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.

Manufacturer Narrative

Corrected type of investigation, investigation findings and investigation conclusions submitted.

Event Description

Cracked hub insertion: (b)(6) 2022.

• 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: 17405345
• MDR Text Key: 319948543
• Report Number: 0001625425-2023-01125
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2023
• 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: 11385286
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/14/2021
• 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): Other; Required Intervention