MAUDE Adverse Event Report: COVIDIEN MEDTRONIC RELIA CATCH CATCH 10 SPECIMEN RETRIEVAL BAG; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	CATCH10
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Relia catch 10 bag ripped, no harm to patient, surgeon used another.Fda safety report id # (b)(4).

• Brand Name: MEDTRONIC RELIA CATCH CATCH 10 SPECIMEN RETRIEVAL BAG
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COVIDIEN; mansfield MA 02048
• MDR Report Key: 11737185
• Report Number: MW5101013
• Device Sequence Number: 14334560
• Product Code: GCJ
• UDI-Device Identifier: 10884521704046
• UDI-Public: (01)10884521704046
• Initial Reporter State: MA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 04/23/2021

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 Expiration Date: 03/19/2024
• Device Model Number: CATCH10
• Device Catalogue Number: CATCH10
• Device Lot Number: C1031921A
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/27/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 77