MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ONE WAY VALVE; CONNECTOR, AIRWAY (EXTENSION)

Catalog Number 1644

Device Problem Break (1069)

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

Event Date 01/02/2018

Event Type  malfunction  

Manufacturer Narrative

Qn#(b)(4).A visual, dimensional, and functional inspection of the device involved in the complaint could not be conducted since the device was not returned at the time of this report.The device history record (dhr) of batch number 74g1700488 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.In order to perform a proper and thorough investigation to confirm the alleged defect, determine the root cause and establish any necessary corrective actions, it is necessary to evaluate the sample involved.If the device sample becomes available at a later date this report will be updated.

Event Description

Customer complaint alleges the device broke during use on a patient.There was no report of patient harm or consequence.There was no report of necessary medical intervention.

Manufacturer Narrative

Qn# (b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the one way valve was disassembled.Based on the visual exam the reported complaint was confirmed.A non-conformance was opened to further address this issue.

Event Description

Customer complaint alleges the device broke during use on a patient.There was no report of patient harm or consequence.There was no report of necessary medical intervention.

• Brand Name: HUDSON ONE WAY VALVE
• Type of Device: CONNECTOR, AIRWAY (EXTENSION)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 7190407
• MDR Text Key: 97545773
• Report Number: 3004365956-2018-00020
• Device Sequence Number: 1
• Product Code: BZA
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

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: 1644
• Device Lot Number: 74G1700488
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/02/2018
• Initial Date FDA Received: 01/15/2018
• Supplement Dates Manufacturer Received: 02/08/2018
• Supplement Dates FDA Received: 02/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/04/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1