MAUDE Adverse Event Report: MEDTRONIC MEXICO CUSTOM TUBING PACK; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO

Model Number	HY10U10R4
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection showed that the qb-inlet port was broken off.The reason for return was confirmed.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Medtronic received information that prior to use of the custom tubing pack, the customer reported that the blood inlet connection site has been broken off, of the fusion oxygenator.The custom tubing pack was replaced for the procedure.There was no patient involvement so no adverse patient effects occurred.Additional information: the customer stated that they believe that the packaging design is the issue.There was no noticeable damage to shipping containers or to the packaging.Other devices in the same box/shipping container were not damaged.

• Brand Name: CUSTOM TUBING PACK
• Common Device Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: alison sweeney ; parkmore business park west; galway ; EI ; 091708096
• MDR Report Key: 13694141
• Report Number: 9612164-2022-00915
• Device Sequence Number: 4930646
• Product Code: DWF
• UDI-Device Identifier: 00763000542139
• UDI-Public: 00763000542139
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K171308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician Assistant
• Type of Report: Initial
• Report Date (Section B): 03/08/2022

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 Expiration Date: 05/18/2023
• Device Model Number: HY10U10R4
• Device Catalogue Number: HY10U10R4
• Device Lot Number: 222374724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/07/2022
• Initial Report FDA Received Date: 03/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown