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

Model Number	BB9R01R8
Medical Device Problem Codes	Crack (1135); Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/18/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Product analysis: visual inspection showed that one of the luer connections could not be separated.The device was observed under magnification and there appeared to be evidence of some solvent residue in the connection.The specification does not show any solvent on that connection.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 the use of a custom tubing pack, the customer reported that the stopcock inside of the custom tubing pack was glued to its adjoining part, where it should not be and that the connector cracked when the perfusionist tried to separate the parts.The device was replaced for the procedure.There was no patient involvement so no adverse effect occurred.

• 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: 13788954
• Report Number: 9612164-2022-01038
• Device Sequence Number: 11738863
• Product Code: DWF
• UDI-Device Identifier: 00763000629748
• UDI-Public: 00763000629748
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 03/16/2022

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: 08/24/2023
• Device Model Number: BB9R01R8
• Device Catalogue Number: BB9R01R8
• Device Lot Number: 223454113
• 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: 02/18/2022
• Initial Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/08/2021
• 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