MAUDE Adverse Event Report: DEROYAL INDUSTRIES INC. CMC VASCULAR PACK; GENERAL SURGERY TRAY

Model Number 89-10581.01

Device Problems Break (1069); Device Contamination with Chemical or Other Material (2944)

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

Event Date 02/18/2021

Event Type  malfunction  

Event Description

While opening room for case, after scrub tech scrubbed and started to set up back table, observed short brown hair on back table cover and tape band around lap sponges was broken/torn.Nothing else was touched at the time.Scrub tech has long silver hair and doesn't match found in pack.Pictures of pack were taken and pack was removed from room.Staff obtained another pack and opened it without incident.Did not delay case.Pack was not saved for quality.Pictures of the pack sheet, the back table cover with hair and lap sponges with broken/torn band were obtained and will be sent to quality.Will review with staff to save all packs and cover sheets to send to quality.Pictures x5 attached to report.

• Brand Name: CMC VASCULAR PACK
• Type of Device: GENERAL SURGERY TRAY
• Manufacturer (Section D): DEROYAL INDUSTRIES INC.; 200 debusk lane; powell TN 37849
• MDR Report Key: 11482108
• MDR Text Key: 239794562
• Report Number: 11482108
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-10581.01
• Device Catalogue Number: 89-10581.01
• Device Lot Number: 53666666
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/23/2021
• Event Location: Hospital
• Date Report to Manufacturer: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Weight: 75