MAUDE Adverse Event Report: ARGON MEDICAL DEVICES L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM

Model Number 384539

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 02/25/2022

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

Picc line placed as replacement picc on per form (b)(6) penn hospital #2 hub cracked and leaked at 1755pm on (b)(6) 2022.Per customer approximately 23 hours after insertion.Picc d/c¿ed.Piv placed because patient on tpn, lipids, and antibiotics this is the same patient as agh west penn hospital per form #2.Patient had two picc insertions within approximately 23 hours.

Manufacturer Narrative

A review of the dhr and inspection records was conducted, and no similar concerns were found.One sample was returned for review.Visual inspection of the returned sample confirmed a crack in the hub which could result in leakage.Several complaints have previously been received regarding a cracked hub resulting in leakage, and capa 2021-039 has been initiated to address this issue and is currently under investigation.The capa will identify the specific causes and corrective actions to be taken.Capa 2021-039 has been initiated to address this issue and is currently under investigation.The capa will identify the specific causes and corrective actions to be taken.

Event Description

Picc line placed as replacement picc on per form agh west penn hospital #2 hub cracked and leaked at 1755pm on 3/13/2022.Per customer approximately 23 hours after insertion.Picc d/c¿ed.Piv placed because patient on tpn, lipids, and antibiotics this is the same patient as agh west penn hospital per form #2.Patient had two picc insertions within approximately 23 hours.

• Brand Name: L-CATH PICC S/L 26GA (1.9F) 0.60MM X 30CM
• 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: 13860404
• MDR Text Key: 295899635
• Report Number: 0001625425-2022-00967
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209934
• UDI-Public: 00886333209934
• 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: 04/25/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 384539
• Device Catalogue Number: 384539
• Device Lot Number: 11403016
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other