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

Catalog Number 400640

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

Patient Problem No Patient Involvement (2645)

Event Date 03/01/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned for evaluation.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed, based only on the information provided.To perform a correct investigation and determine the source of defect reported it is necessary to evaluate the sample involved in this complaint.An attempt to duplicate the failure mode was made, but at the time there is no inventory of the involved product code (400640; aquapak 640 sw,650 ml w/040 adaptor,intl) available at the facility nor being manufactured at the time.A capa file (b)(4) was opened to perform a further investigation this issue (this capa is owned by r and d).According to the capa investigation, so far, the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.If the device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the aquapak adaptor does not fit properly to the flow meter and due to this the adaptor broke.

• Brand Name: HUDSON AQUAPAK 640 SW,650 ML W/040 ADAPTOR,INT
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5574216
• MDR Text Key: 42559736
• Report Number: 1417411-2016-00053
• Device Sequence Number: 1
• Product Code: OGG
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 04/05/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 400640
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/05/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: FLOW METER