MAUDE Adverse Event Report: ARGON MEDICAL DEVICES SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM

Model Number 701116090

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/29/2024

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

A facility reported that during a bone biopsy procedure, the needle became totally disconnected from the hub during the acquisition of a sample.This resulted in a large blood spray covering the physician and equipment.There was no patient injury.

Manufacturer Narrative

Additional information provided in h.3., h.6.And h.10.After three notifications, no product was returned for evaluation.An image of the device was provided.The image showed the device split distally, and the complaint was confirmed.Without the actual device the examine, a definitive root cause could not be determined.A review of the batch records confirmed that the product was manufactured according to specification and no deviations or anomalies were found.Argon is currently exploring options to mitigate the possiblity of recurrence of this issue.If the sample is returned at a future date, this complaint may be reopened for further evaluation at that time.There have been no other complaints reported in the lot.

• Brand Name: SUPERCORE BIOPSY INSTRUMENT 16GA X 9CM
• Type of Device: SUPERCORE BIOPSY INSTRUMENT
• Manufacturer (Section D): ARGON MEDICAL DEVICES; 1445 flat creek rd; athens TX 75751
• Manufacturer Contact: kelly mayer ; 1445 flat creek rd; athens, TX 75751 ; 9036759321
• MDR Report Key: 18793159
• MDR Text Key: 336434804
• Report Number: 0001625425-2024-00938
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974814
• 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: 05/13/2024

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 Operator: Health Professional
• Device Model Number: 701116090
• Device Lot Number: 11491096
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 01/30/2024
• Initial Date FDA Received: 02/27/2024
• Supplement Dates Manufacturer Received: 04/17/2024
• Supplement Dates FDA Received: 05/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/03/2023
• 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