MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 301 SW,340 ML,INTL; BUBBLE HUMIDIFIER

Catalog Number 400301

Device Problems Restricted Flow rate (1248); Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 06/05/2015

Event Type  malfunction  

Event Description

The customer alleges that the adaptor is difficult to screw tightly to the flowmeter and that not enough oxygen flow.No patient injury.

Manufacturer Narrative

Qn#(b)(4).The device sample was received by the manufacturer, but the investigation is incomplete at the time of this report.Based on the lot 537147 provided for which the dhr resides at (b)(4) lot numbers for component mp-0321 were obtained.Records reviewed showed that there were no issues related to functional issues on the molded component involved in this complaint (b)(4) (snap-on flowmeter adaptor) batch # 1-2114742, 2-2114742, 3-2114741, 3-2114742, 4-2114741, 4-2114742 during the manufacture of the material.Regarding other customer complaints from this same issue, a capa file #(b)(4) was opened.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was damage on the thread of the adaptor.Based on the visual exam, the reported complaint was confirmed.All personnel from the molding area related to this process were notified.Also a capa was opened to further investigate this issue.

Event Description

The customer alleges that the adaptor is difficult to screw tightly to the flowmeter and that not enough oxygen flow.No patient injury.

• Brand Name: HUDSON AQUAPAK 301 SW,340 ML,INTL
• Type of Device: BUBBLE HUMIDIFIER
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; 900 west university dr.; arlington heights IL 60004
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4953306
• MDR Text Key: 6034307
• Report Number: 1417411-2015-00130
• Device Sequence Number: 1
• Product Code: BTT
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative,company represent
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 07/06/2015

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: Other
• Device Catalogue Number: 400301
• Device Lot Number: 537147
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/06/2015
• Initial Date FDA Received: 07/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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