MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO

Catalog Number 7140

Device Problem Leak/Splash (1354)

Patient Problem No Patient Involvement (2645)

Event Date 04/26/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not received by the manufacturer at the time of this report.The device history record (dhr) has been reviewed, and no issues or discrepancies were found which could potentially relate to this complaint.The dhr shows that the product was assembled and inspected according to our specifications.Customer complaint cannot be confirmed based only on the information provided.No corrective action can be established at this time.Root cause is unknown.In order to perform a proper and thorough investigation and determine the source of alleged defect reported it is necessary to evaluate the sample involved on this complaint.If defective sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges "it was reported that after the product was connected to an anesthetic apparatus, a pre-use inspection was conducted.At that time, leak alarm occurred." it was reported that a new device was opened for use.It was reported there was no patient involvement.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and no defects were observed.The sample was functionally tested using a leak tester.The actual test leak value for the set was 3 ml/min.This value is well below the high end range value of 70 ml/min.The complaint cannot be confirmed.The 3 liter bag was attached to the anesthesia circuit, compressed air was allowed to flow into the bag until all of the fold cresses were fully expanded and the bag was "tight" to the feel.The expanded bag and the bag connection point were completely submerged into a bath of plain water to determine if the bag was leaking air.There were no bubbles coming from the bag or the bag connection point indicating the bag was not damaged.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned device.

Event Description

Customer complaint alleges "it was reported that after the product was connected to an anesthetic apparatus, a pre-use inspection was conducted.At that time, leak alarm occurred." it was reported that a new device was opened for use.It was reported there was no patient involvement.

• Brand Name: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
• Type of Device: CIRCUIT, BREATHING (W CONNECTO
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7506719
• MDR Text Key: 108003374
• Report Number: 3004365956-2018-00161
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 04/26/2018

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: 7140
• Device Lot Number: 74B1502824
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/21/2018
• Initial Date Manufacturer Received: 04/26/2018
• Initial Date FDA Received: 05/11/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1