MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MINOR PACK; LAPAROSCOPY KIT

Model Number DYNJ49355

Device Problems Contamination (1120); Packaging Problem (3007)

Patient Problem Insufficient Information (4580)

Event Date 03/12/2021

Event Type  malfunction  

Event Description

Residual styrofoam from minor pack tray was adhered to bulb syringe presenting an opportunity of introducing a foreign body into the patient during surgery.There was a conversion to cardboard trays that was supposed to occur some time ago to avoid this potential issue in the future, but this has not yet occurred.Fda safety report id# (b)(4).

• Brand Name: MINOR PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. ; northfield IL 60093
• MDR Report Key: 11506882
• MDR Text Key: 240790932
• Report Number: MW5100058
• Device Sequence Number: 1
• Product Code: FDE
• 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: 03/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: DYNJ49355
• Device Catalogue Number: DYNJ49355
• Device Lot Number: 20HBL613
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 51 YR