MAUDE Adverse Event Report: TELEFLEX INCORPORATED PLEUR-EVAC; BOTTLE, COLLECTION, VACUUM

Model Number	IPN028442
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Patient was placed on a pleur-evac following open heart surgery.In the surgical icu, it was noted that the pleur-evac failed as it would not keep suction.The pleur-evac was changed, which resolved the air leak.

• Brand Name: PLEUR-EVAC
• Common Device Name: BOTTLE, COLLECTION, VACUUM
• Manufacturer (Section D): TELEFLEX INCORPORATED; 3015 carrington mill blvd.; morrisville NC 27560
• MDR Report Key: 17412846
• Report Number: 17412846
• Device Sequence Number: 17901899
• Product Code: KDQ
• UDI-Device Identifier: 14026704631237
• UDI-Public: (01)14026704631237(17)251207(10)74M2200818
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2023
• Report Date (Section F): 07/06/2023

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 Model Number: IPN028442
• Device Catalogue Number: A-6000-08LF
• Device Lot Number: 74M2200818
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/28/2023
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/28/2023
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/06/2023