MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. PRO-MAG¿ BIOPSY NEEDLES

Catalog Number 765016160

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

The device has not been returned for evaluation and no images have been provided of the device, so the complaint cannot be confirmed.If additional information is provided in the future, this issue will be reevaluated as needed.

Event Description

When the doctor wanted to remove the needle during the biopsy, he realized that it was not fixed in the holder.

Manufacturer Narrative

The sample device was returned for evaluation.A visual inspection found the pro-mag cannula snap fit hole was damaged, confirming the customer''s complaint.The hub more than likely came out of the integral spacer post-manufacture.The hubs can be placed within the integral spacer if it comes out.A conclusive cause could not be determined.No corrective action will be taken at this time.H3 other text : placeholder.

• Brand Name: PRO-MAG¿ BIOPSY NEEDLES
• Type of Device: BIOPSY NEEDLES
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek road; athens TX 75751
• MDR Report Key: 8978322
• MDR Text Key: 158620329
• Report Number: 1625425-2019-00248
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): Y
• PMA/PMN Number: K980226
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/01/2005,08/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/02/2023
• Device Catalogue Number: 765016160
• Device Lot Number: 11232915
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/01/2005
• Date Report to Manufacturer: 01/10/2005
• Date Manufacturer Received: 01/14/2005
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other