MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. - SPT CYSTO PACK; LAPAROSCOPY KIT

Catalog Number CMPJ08198A

Device Problems Use of Device Problem (1670); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 05/20/2021

Event Type  malfunction  

Event Description

Cysto pack tore upon opening at the sticky tape.Pack was unable to be used.Fda safety report id # (b)(4).

• Brand Name: CYSTO PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC. - SPT
• MDR Report Key: 11991312
• MDR Text Key: 256183204
• Report Number: MW5101845
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 06/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2023
• Device Catalogue Number: CMPJ08198A
• Device Lot Number: 21CBP673
• Was Device Available for Evaluation?: Yes
• 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