MAUDE Adverse Event Report: AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.) ENT SURGICAL KIT; TRAY, SURGICAL, ENT

Lot Number 1545427

Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/06/2023

Event Type  malfunction  

Event Description

Preparing to conduct an ent surgery on (b)(6) 2023.An rn was reviewing the equipment and materials from the surgical ent pack that was planned to be used for this surgery, he observed small metal shavings in a piece of equipment (called the basin).Upon closer inspection, it was apparent that the curvature of the shavings matched that of the pin in the center of the towel clamps, which is also included in the same ent pack.The surgical ent packs which are used for ent surgeries all utilize the same model of towel clamps, which means that the there is potential for the same exact issue regarding the presence of metal shavings in the basin to reoccur for this type of procedure in the future.If any metal shavings which derive from the towel clamps in a surgical ent pack are not discovered and removed from the basin before an ent surgery takes place, then they would be drawn into a bulb syringe and carried into a patient's wound with irrigation, causing retention of a foreign object.The rn removed the basin from the field before the patient entered the room.The equipment from this surgical ent pack (the basin, metal scrap, and towel clamp) was promptly removed and stored in the manager's office for further observation.In response to the discovery of metal shavings within the surgical ent packs, an email was sent out to employees advising staff to be on the lookout for metal shavings from towel clamps whenever using a surgical ent pack.On (b)(6) 2023, another ent surgical pack was discovered to have metal shavings from its towel clamps and was confiscated before the planned procure took place.Logistics was notified immediately, and an investigation was conducted.The investigation's findings discovered that the presence of metal shavings was present in two different packs from the surgical ent pack inventory.These surgical ent packs were removed from inventory, and the manufacturer was contacted about the issue.The national center of patient safety and the visn were also notified about this finding.Manus medical.Reference report: mw5115750.

• Brand Name: ENT SURGICAL KIT
• Type of Device: TRAY, SURGICAL, ENT
• Manufacturer (Section D): AVANOS MEDICAL, INC. (FORMERLY HALYARD HEALTH INC.)
• MDR Report Key: 16546611
• MDR Text Key: 311409394
• Report Number: MW5115751
• Device Sequence Number: 1
• Product Code: MMO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Lot Number: 1545427
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1