MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - LAREDO MINOR PACK; LAPAROSCOPY KIT

Model Number DYNJ49355

Device Problems Component Missing (2306); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 03/17/2022

Event Type  malfunction  

Event Description

Medline minor pack had only 4 of 5 large sponges in the pack.Fda safety report id# (b)(4).

• Brand Name: MINOR PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - LAREDO
• MDR Report Key: 13847875
• MDR Text Key: 287789014
• Report Number: MW5108397
• Device Sequence Number: 1
• Product Code: FDE
• 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: 03/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: DYNJ49355
• Device Catalogue Number: DYNJ49355
• Device Lot Number: 22ABF607
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White