MAUDE Adverse Event Report: ARGON MEDICAL DEVICES INC. T-LOK BONE MARROW

Catalog Number DBMNJ0804TL

Device Problems Hole In Material (1293); Nonstandard Device (1420); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 06/29/2015

Event Type  malfunction  

Manufacturer Narrative

The hole in the tray was discovered after they were instructed by argon medical devices to examine product in their inventory for holes.The device from the complaint lot has not been returned to argon medical devices for eval as of the date of this report, (b)(6) 2015.However, the image provided confirms the of a hole in the lower right corner of the blister compartment.Based on previous complaints, argon had initiated a 100% re-screen of similar devices in argon's inventories.A health hazard assessment was completed on (b)(6) 2015 and argon initiated a recall.The fda (b)(4) district was notified of this decision on 06/18/2015.There have been no reports of infection or pt harm.The product label cautions the user to not use the product if the package or product is damaged, and the holes are large enough to be seen on visual examination.

Event Description

A hole was found in one tray of packaged product.

• Brand Name: T-LOK BONE MARROW
• Type of Device: T-LOK BONE MARROW
• Manufacturer (Section D): ARGON MEDICAL DEVICES INC.; 1445 flat creek rd.; athens TX 75751
• Manufacturer Contact: gail smith ; 1445 flat creek rd.; athens, TX 75751 ; 2144368995
• MDR Report Key: 4954230
• MDR Text Key: 23448454
• Report Number: 1625425-2015-00032
• Device Sequence Number: 1
• Product Code: KNW
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K980196
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Not Applicable
• Remedial Action: Recall
• Report Date: 07/24/2015

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 Expiration Date: 02/28/2020
• Device Catalogue Number: DBMNJ0804TL
• Device Lot Number: 11093019
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/01/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1