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

Model Number	DYNJ35353F
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/29/2022
Type of Reportable Event	Malfunction
Event or Problem 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
• Common Device Name: LAPAROSCOPY KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline place; mundelein IL 60060
• MDR Report Key: 15182469
• Report Number: 15182469
• Device Sequence Number: 14905088
• Product Code: FDE
• UDI-Device Identifier: 10888277744264
• UDI-Public: (01)10888277744264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/30/2022
• Report Date (Section F): 07/30/2022

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
• Operator of Device: 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
• Event Location: Hospital
• Date Report to Manufacturer: 08/08/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female
• Date Report Sent to FDA: 07/30/2022