MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,FRE; HUMIDIFIER NEBULIZER KIT

Catalog Number 006-40F

Device Problems Break (1069); Connection Problem (2900)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2018

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, or a photo of the alleged defect was not received at the time of this report.Based on the lot 171416 provided for which the device history record resides at (b)(4), the nuevo laredo lot numbers for component 12228 were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint 12228 (adaptor, snap-on flowmeter, french) during the manufacture of the material.Customer complaint cannot be confirmed based only on the information provided.No corrective actions can be established.It is necessary to have the device sample involved to perform a proper and thorough investigation to confirm the alleged defect and determine a root cause.Device availablity has been requested by teleflex.If the device sample becomes available at a later date this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the adaptor connection to the aquapak breaks too easily".Alleged defect reported a occurred during use.Customer reports no patient impact or consequence.

Manufacturer Narrative

(b)(4).One sample was received for evaluation of catalog number 006-40f (aquapak 640 sw, 650 ml w/040 adaptor, fren).However the sample was received incomplete.It is without component pn 12228 "adaptor, snap-on flowmeter.Due to incomplete sample return complete visual inspection could not be performed.Functional, and dimensional evaluation could not be performed due to the received sample was incomplete.Customer complaint cannot be confirmed, based on the received sample, since it was received incomplete (without component pn 12228 "adaptor, snap-on flowmeter, french").To perform a proper investigation and determine the source of reported defect the complete sample is needed.If the missing component of this sample (pn 12228) becomes available at a later date this report will be updated.Teleflex will continue to monitor and trend for complaints of this nature.

Event Description

Customer complaint alleges "the adaptor connection to the aquapak breaks too easily".Alleged defect reported a occurred during use.Customer reports no patient impact or consequence.

• Brand Name: HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,FRE
• Type of Device: HUMIDIFIER NEBULIZER KIT
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7519568
• MDR Text Key: 108488493
• Report Number: 1417411-2018-00031
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/13/2021
• Device Catalogue Number: 006-40F
• Device Lot Number: 171416
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/29/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/13/2017
• 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