MAUDE Adverse Event Report: MALLINCKRODT DAR SRL DAR; CATHETERS, SUCTION, TRACHEOBRONCHIAL

Model Number 444S02608

Device Problem Material Separation (1562)

Patient Problems Airway Obstruction (1699); Hypoventilation (1916)

Event Date 01/17/2024

Event Type  Injury  

Event Description

According to the reporter, the device had breakage on the y-piece portion which resulted in airway obstruction and not being permeable for ventilation.

Manufacturer Narrative

D10 concomitant product: 44s02608, 444s02608 8ch neo/paed ty-care w y pc, (lot #22e1253fax) 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.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: DAR
• Type of Device: CATHETERS, SUCTION, TRACHEOBRONCHIAL
• Manufacturer (Section D): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer (Section G): MALLINCKRODT DAR SRL; via giacomo bove 2/4/6/8; mirandola 41037 ; IT 41037
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 18700213
• MDR Text Key: 335296736
• Report Number: 2936999-2024-00316
• Device Sequence Number: 1
• Product Code: BSY
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K031997
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/13/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 444S02608
• Device Catalogue Number: 444S02608
• Device Lot Number: 22E1253FAX
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/17/2024
• Date Device Manufactured: 07/07/2022
• 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
• Patient Outcome(s): Life Threatening