MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE RAYTECS BSC LAP SRG PROC ; LAPAROSCOPY KIT

Model Number DYNJ0604482AA

Device Problem Material Separation (1562)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/30/2019

Event Type  Injury  

Event Description

Raytec's from medline basic lap pack was falling apart before it was used on the pt.Raytecs from the pack were thrown off the field and new ones were used.No issues or harm to the pt.Filled out product failure sheet and notified management.Fda safety report id# (b)(4).

• Brand Name: MEDLINE RAYTECS BSC LAP SRG PROC
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.
• MDR Report Key: 9569529
• MDR Text Key: 174666345
• Report Number: MW5092122
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 01/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/08/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ0604482AA
• Device Catalogue Number: DYNJ0604482AA
• Device Lot Number: 19KKA041
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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 Outcome(s): Required Intervention
• Patient Age: 36 YR
• Patient Weight: 85