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

Model Number BB10R29R9

Device Problems Break (1069); Disconnection (1171)

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

Event Date 02/03/2022

Event Type  malfunction  

Event Description

Medtronic received information that prior to use of this custom tubing pack the customer noticed that the pressure line was broken within the pack.There was no patient involvement so no adverse patient effects occurred.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

Additional information received stated that the pressure line that was supposed to be pre-connected to a 1/4 x 1/4 luer connector was broken at the connection site.The male end remained attached but the tubing was separated.There was no visible damage to the packaging or surrounding items.The tubing was replaced with standard pressure tubing for the procedure and this was used without incident.It was also reported that the inlet port of the fusion oxygenator was also broken.The port was completely broken off.As the additional information confirmed that there reported breaks were complete, and noted prior to use, this device would be unusable for the procedure, and so there is no risk of patient death or serious injury.Device evaluation summary: visual inspection shows the luer fitting is missing from one end of the returned tubing.Photo provided by the customer shows the luer fitting loose inside the pack.Note: the luer fitting was not returned with the tubing.Reason for return was confirmed.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CUSTOM TUBING PACK
• Type of Device: 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: 13547876
• MDR Text Key: 285732439
• Report Number: 9612164-2022-00657
• Device Sequence Number: 1
• Product Code: DWF
• UDI-Device Identifier: 00763000369798
• UDI-Public: 00763000369798
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician Assistant
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2023
• Device Model Number: BB10R29R9
• Device Catalogue Number: BB10R29R9
• Device Lot Number: 222941499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/03/2022
• Initial Date FDA Received: 02/17/2022
• Supplement Dates Manufacturer Received: 02/28/2022
• Supplement Dates FDA Received: 03/29/2022
• Date Device Manufactured: 09/14/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1