MAUDE Adverse Event Report: MEDLINE INDUSTRIES. INC. MEDLINE TOTAL KNEE PACK; ORTHOPEDIC TRAY

Catalog Number DYNJ42553C

Device Problems Delivered as Unsterile Product (1421); Tear, Rip or Hole in Device Packaging (2385)

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

Event Type  No Answer Provided  

Event Description

Hole in major knee pack.Upon opening knee pack for sterile field, a hole was seen, pack was removed from the room, and a new opened.Patient was not in the room and unsterile pack did not reach the patient.

• Brand Name: MEDLINE TOTAL KNEE PACK
• Type of Device: ORTHOPEDIC TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES. INC.
• MDR Report Key: 9631846
• MDR Text Key: 176622375
• Report Number: MW5092489
• Device Sequence Number: 1
• Product Code: OJH
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial

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?: No
• Device Operator: No Information
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: DYNJ42553C
• Device Lot Number: 19VBH452
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/24/2020
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 64 YR