MAUDE Adverse Event Report: TELEFLEX MEDICAL SDN. BHD. HUDSON BACTERIAL/VIRAL FILTER; FILTER, BACTERIAL, BREATHING-C

Model Number IPN042652

Device Problem Complete Blockage (1094)

Patient Problem Airway Obstruction (1699)

Event Date 01/27/2021

Event Type  Injury  

Manufacturer Narrative

(b)(4).

Event Description

Customer reported the plastic piece that connects to the patient et tube and hooks to circuit was blocked by an uncut piece of plastic."patient induced under general anesthesia, lma applied.Unable to have return of etco2.Changed lma to ett and intubated patient, grade 1 view.No etco2, high peak airway pressures.Pt had history of asthma, so suspected bronchospasm (occlusion of the airway of some sort).Reconfirmed by dl ett was in trachea, mask ventilation albuterol given.Called for help.Epinephrine given.Ett suctioned with no obstruction noted.Still no etco2 and high peak airway pressures.Changed patient from ventilator to ambu bag and immediate fogging of ett and bilateral breath sounds so occlusion was in the anesthesia ventilator circuit.Removed the viral filter from the circuit and immediate etco2 with normal peak airway pressures." the customer reported upon inspection there was "an entire plastic piece" that occluded the filter and made a "complete obstruction to the patient's airway".Patient condition unknown at time of report.

Manufacturer Narrative

Qn# (b)(4).The actual sample was not returned; therefore a representative sample was taken from production at the manufacturing site.A visual exam was performed on the representative sample and no defects were observed.A device history record review was performed and no relevant findings were identified.Without the actual device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

Customer reported the plastic piece that connects to the patient et tube and hooks to circuit was blocked by an uncut piece of plastic."patient induced under general anesthesia, lma applied.Unable to have return of etco2.Changed lma to ett and intubated patient, grade 1 view.No etco2, high peak airway pressures.Pt had history of asthma, so suspected bronchospasm (occlusion of the airway of some sort).Reconfirmed by dl ett was in trachea, mask ventilation albuterol given.Called for help.Epinephrine given.Ett suctioned with no obstruction noted.Still no etco2 and high peak airway pressures.Changed patient from ventilator to ambu bag and immediate fogging of ett and bilateral breath sounds so occlusion was in the anesthesia ventilator circuit.Removed the viral filter from the circuit and immediate etco2 with normal peak airway pressures." the customer reported upon inspection there was "an entire plastic piece" that occluded the filter and made a "complete obstruction to the patient's airway".Patient condition unknown at time of report.

• Brand Name: HUDSON BACTERIAL/VIRAL FILTER
• Type of Device: FILTER, BACTERIAL, BREATHING-C
• Manufacturer (Section D): TELEFLEX MEDICAL SDN. BHD.; perak, west malaysia
• MDR Report Key: 11348093
• MDR Text Key: 232553993
• Report Number: 8040412-2021-00030
• Device Sequence Number: 1
• Product Code: CAH
• UDI-Device Identifier: 04026704399208
• UDI-Public: 04026704399208
• Combination Product (y/n): N
• PMA/PMN Number: K961914
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 01/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN042652
• Device Catalogue Number: 1605
• Device Lot Number: KMZ20J0600
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 03/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: LMA, ETT; LMA, ETT; LMA, ETT
• Patient Outcome(s): Life Threatening; Required Intervention