MAUDE Adverse Event Report: ST PAUL PORTEX UNCUFFED NEONATAL/PEDIATRIC TRACHEAL TUBES; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	21-7034-24
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.A product sample was received for evaluation.Visual testing was performed.Visual inspection found the male luer was broken.The root cause of the reported issue was found to be that the material was damaged after it left shm facility, due to the fact the defect mentioned on this report is easily detectable by the inspection and assembly operations performed per production and quality personnel before the packaging process.
Event or Problem Description
It was reported that during the purge, the tubing was severed near the immunotherapy's connector bag.No patient injury was reported.
Additional Manufacturer Narrative
While performing a review of submitted mdr report it was discovered that this file was inadvertently assessed as reportable.No patient death, serious injury, and no evidence of a reportable product malfunction.The hazardous situation for the given complaint device would not likely cause or contribute to a death or serious injury if the malfunction were to recur.File (b)(4) is no longer considered reportable, please disregard any mdr reports associated with it.

• Brand Name: PORTEX UNCUFFED NEONATAL/PEDIATRIC TRACHEAL TUBES
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14313505
• Report Number: 3012307300-2022-07925
• Device Sequence Number: 5000390
• Product Code: FPA
• UDI-Device Identifier: 10610586020162
• UDI-Public: 10610586020162
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K895046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 05/26/2022

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: 07/26/2024
• Device Model Number: 21-7034-24
• Device Catalogue Number: 7034
• Device Lot Number: 3848057
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 09/28/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/28/2020
• Supplement Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 05/07/2022
• Supplement Report FDA Received Date: 05/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/12/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-0148-2022
• Patient Sequence Number: 1
• Patient Sex: Unknown