MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - SPT PLASTIC MAJOR PACK; PLASTIC SURGERY AND ACCESSORIES KIT

Model Number DYNJ49360

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

Patient Problem Insufficient Information (4580)

Event Date 02/07/2022

Event Type  malfunction  

Event Description

Medline plastic major pack had incorrect number of sponges (4 vs.5) in one of the sponge packs.These counts are critical for sponge accountability in the operating room.Fda safety report id # (b)(4).

Event Description

Medline plastic major pack had incorrect number of sponges (4 vs.5) in one of the sponge packs.These counts are critical for sponge accountability in the operating room.Fda safety report id # (b)(4).

• Brand Name: PLASTIC MAJOR PACK
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - SPT
• MDR Report Key: 13506463
• MDR Text Key: 285530738
• Report Number: MW5107354
• Device Sequence Number: 1
• Product Code: FTN
• 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
• Report Date: 02/07/2022

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: 08/31/2023
• Device Model Number: DYNJ49360
• Device Catalogue Number: DYNJ49360
• Device Lot Number: 21KBH740
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/09/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1