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

Catalog Number 311403

Device Problem Gas/Air Leak (2946)

Patient Problem No Patient Involvement (2645)

Event Date 11/04/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved was not received for evaluation by the manufacturer at the time of this report.The device history record (dhr) of batch number 74k1702308 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Customer complaint cannot be confirmed based only on the information provided.To perform a proper investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved in this complaint.Root cause cannot be determined.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 "they found that the circuit presented a leakage.Found prior to use on a patient during inspection/functional testing." no patient involvement was reported.

Manufacturer Narrative

(b)(4).One (1) dual limb 311403 breathing circuit, anesthesia, adult, expiratory 0.5-1.8m w/ex was returned for investigation.A visual inspection was performed to examine the sample for any signs of abuse/misuse/damage.None were noted.The circuit was setup for a leak test on a lab leak tester.The ventilator tubing sets were tested at 60 +/- 3 cm h2o of pressure with incoming equipment pressure set a 30 psi.The acceptable leak value is = 30 ml/min.The actual ml/min pressure recorded at test was 14ml/min.The circuit does leak, but within the established iso acceptable parameters.The complaint sample was tested against iso standard 5367 annex e which states at 60 +/- 3 cm h2o of pressure with incoming equipment pressure set a 30 psi the acceptable leak value is = 30 ml/min.The sample was well within the iso specified leakage value.

Event Description

Customer complaint alleges "they found that the circuit presented a leakage.Found prior to use on a patient during inspection/functional testing." no patient involvement was reported.

• Brand Name: HUDSON BREATH CIRC,ANES,ADULT,EXP 0.5-1.8M
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 8151267
• MDR Text Key: 130049913
• Report Number: 3004365956-2018-00346
• 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
• Type of Report: Initial,Followup
• Report Date: 11/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• 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: 74K1702308
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2018
• Date Manufacturer Received: 01/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.