MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M W/E; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 311403

Device Problem Gas/Air Leak (2946)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/16/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.The device history record of the batch number reported has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.To perform a proper investigation and determine the source of alleged defect reported, it is necessary to evaluate the sample involved.Customer complaint cannot be confirmed based only on the information provided.Root cause is unknown.No corrective action can be established.If the device sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges "that during a test for the quantity of air that escapes the system, they found that the circuit presented an air leakage.Found prior to use on a patient during inspection/functional testing".

Manufacturer Narrative

(b)(4).Received one (1) 311403 breath circuit , anesthesia , adult , expiratory 0.5-1.8m w/ex.The components received: one dual limb collapsible circuit, one ventilator to heater jump line, one breathing bag.All pieces were visually inspected for any signs of abuse/misuse/damage.Nothing was noted.The dual limb anesthesia circuit was connected with the proper hardware to a lab leak tester.Incoming air pressure was dialed in at 30 psi.The dialed in leak test pressure was set at 60 cmh2o, +/- 3.The final leak test value was established at 8.0 - 9.0 ml/min.The acceptable leak rate is set at maximum allowable 30 ml/min.The leak rate for the dual limb anesthesia circuit was well within the leak rate value.The jump line was also tested.Applying the same setup hardware and test values, the leak rate value for the jump line could not be established due to a puncture in the tubing.The jump line tube failed leak testing due to a profuse puncture in the tubing.The puncture in the jump line limb is severe which would not allow a leak rate value to be recorded.All breathing/ventilator/anesthesia circuits are pressure tested 100% at the manufacturing site before shipment.The puncture in jump line limb does not appear as though it was caused by a manufacturing process.It appears to be a random puncture without any uniform characteristics.A root cause could not be established.

Event Description

Customer complaint alleges "that during a test for the quantity of air that escapes the system, they found that the circuit presented an air leakage.Found prior to use on a patient during inspection/functional testing".

• Brand Name: HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M W/E
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8021025
• MDR Text Key: 125612143
• Report Number: 3004365956-2018-00328
• Device Sequence Number: 1
• Product Code: CAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 10/22/2018

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 Operator: No Information
• Device Catalogue Number: 311403
• Device Lot Number: 74G1701598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/05/2018
• Initial Date Manufacturer Received: 10/22/2018
• Initial Date FDA Received: 10/30/2018
• Supplement Dates Manufacturer Received: 11/16/2018
• Supplement Dates FDA Received: 12/18/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.