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

Model Number DYNJ35353F

Device Problem Break (1069)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/29/2022

Event Type  malfunction  

Event Description

Pt here for a lap chole, while after the trocar was inserted the syringe that is used in inflate the balloon broke.The trocar and syringe was sequestered and given to me the director.A second trocar was used and the procedure continued as scheduled.System sent materials management for return to vendor.

• Brand Name: LAP CHOLE PACK
• Type of Device: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15182469
• MDR Text Key: 297426207
• Report Number: 15182469
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10888277744264
• UDI-Public: (01)10888277744264
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/30/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ35353F
• Device Catalogue Number: DYNJ35353F
• Device Lot Number: (10)22EMC617
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/30/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female