MAUDE Adverse Event Report: TELEFLEX MEDICAL PE DRY/WET CONT REINFUSION LF 6/CS; APPARATUS, AUTOTRANSFUSION

Model Number	IPN028454
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/15/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
Medwatch # (b)(4).Large pneumothorax noted on routine morning chest x-ray.Determined to be caused by an air leak in the pleur-evac.Patient was not in distress but did have some pain and coughing.Air leak fixed and lung re-expanded.
Additional Manufacturer Narrative
Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
Event or Problem Description
Medwatch #(b)(4).Large pneumothorax noted on routine morning chest x-ray.Determined to be caused by an air leak in the pleur-evac.Patient was not in distress but did have some pain and coughing.Air leak fixed and lung re-expanded.
Additional Manufacturer Narrative
(b)(4).A dhr review could not be conducted since the lot number was not provided.No corrective action can be established at this moment since the product sample is not available for evaluation.Product sample is necessary to perform a proper investigation to determinate the root cause and the corresponding corrective actions.Customer complaint cannot be confirmed due the lack of defective sample to perform a proper investigation and determine the root cause.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility neither is being manufactured at the time.

• Brand Name: PE DRY/WET CONT REINFUSION LF 6/CS
• Common Device Name: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 12829231
• Report Number: 3004365956-2021-00308
• Device Sequence Number: 4780271
• Product Code: CAC
• UDI-Device Identifier: 14026704631350
• UDI-Public: 14026704631350
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K140197
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN028454
• Device Catalogue Number: A-9250LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/05/2021
• Supplement Date Received by Manufacturer: 11/18/2021
• Initial Report FDA Received Date: 11/17/2021
• Supplement Report FDA Received Date: 12/08/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG