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

Model Number IPN028454

Device Problem Leak/Splash (1354)

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

Event Date 02/15/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

Qn# (b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.

Event 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.

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
• Type of Device: 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
• MDR Text Key: 280932395
• Report Number: 3004365956-2021-00308
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 14026704631350
• UDI-Public: 14026704631350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K140197
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: IPN028454
• Device Catalogue Number: A-9250LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 80 KG