MAUDE Adverse Event Report: ARGON MEDICAL DEVICES FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN

Model Number 384221

Device Problem Crack (1135)

Patient Problem Rupture (2208)

Event Date 04/12/2023

Event Type  malfunction  

Event Description

¿when puncturing the patient's cephalic and jugular vein, the two introducer units presented silicone cracking, making it impossible to pass the catheter, as well as rupturing the blood vessel.¿.

Manufacturer Narrative

According to the product experience report, there was no sample to be returned.Additionally, no photographic or visual evidence of any kind was provided which would have allowed for the allegation to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause and corrective action is not possible.If the sample is returned at a future date, a follow-up report will be submitted.

• Brand Name: FIRST PICC S/L BASIC KIT 26GA (1.9F) X 50CM 1 LUMEN
• Type of Device: FIRST 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: 17107842
• MDR Text Key: 316974783
• Report Number: 0001625425-2023-01099
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00886333209743
• UDI-Public: 00886333209743
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K972262
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/12/2023

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: 384221
• Device Catalogue Number: 384221
• Device Lot Number: 11427030
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/23/2023
• Initial Date FDA Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/24/2022
• 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