MAUDE Adverse Event Report: MEDLINE INDUSTRIES - MUNDELEIN C- SECTION PACK; CESAREAN SECTION TRAY

Lot Number 19KBX099

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 04/14/2020

Event Type  malfunction  

Event Description

C section pack was opened for case.Upon opening, noticed soiled spot on sterile operating room table cover.Pack was immediately removed and replaced.Fda safety report id# (b)(4).

• Brand Name: C- SECTION PACK
• Type of Device: CESAREAN SECTION TRAY
• Manufacturer (Section D): MEDLINE INDUSTRIES - MUNDELEIN; northfield IL 60093
• MDR Report Key: 10020617
• MDR Text Key: 189881710
• Report Number: MW5094352
• Device Sequence Number: 1
• Product Code: OHM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/30/2020

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: 04/30/2022
• Device Lot Number: 19KBX099
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/01/2020
• 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: 28 YR