MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SPLITTABLE NEEDLE INTRODUCER 14GA X 6.5CM

Model Number 384073

Device Problems Component Missing (2306); Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/27/2023

Event Type  Injury  

Manufacturer Narrative

Sample is not available for return.Event is being investigated and a follow-up report will be submitted upon investigation conclusion.

Event Description

I picked up some needles and one didnt have a guard on it and it jabbed me in the hand (left palm of hand).

Manufacturer Narrative

A review of the manufacturing and inspection records for this lot was conducted, and no deviations or non-conformances were recorded relating to this issue.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 complaint to be reviewed.Without such evidence, this complaint could not be confirmed and determining a definite root cause is not possible.The packaging supervisor was made aware of the complaint and training was provided to ensure proper handling and assembly of products.Argon will continue to monitor for complaints of this nature.

Event Description

I picked up some needles and one didn't have a guard on it and it jabbed me in the hand (left palm of hand).

• Brand Name: SPLITTABLE NEEDLE INTRODUCER 14GA X 6.5CM
• Type of Device: SPLITTABLE NEEDLE INTRODUCER
• 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: 17015405
• MDR Text Key: 316092494
• Report Number: 0001625425-2023-01066
• Device Sequence Number: 1
• Product Code: FIE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: N/A
• 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: 06/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: 384073
• Device Lot Number: 11450912
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/27/2023
• Initial Date FDA Received: 05/27/2023
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 06/15/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2022
• 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