MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE

Catalog Number 031-33J

Device Problems Air Leak (1008); Connection Problem (2900)

Patient Problems No Consequences Or Impact To Patient (2199); No Patient Involvement (2645)

Event Date 06/15/2015

Event Type  malfunction  

Event Description

The customer alleges that an air leak occurred because the adaptor didn't fit with the oxygen flow meter.

Manufacturer Narrative

(b)(4).The device sample was received by the manufacturer, but the investigation report is incomplete at the time of this report.The device history record of the product 031-33j with batch number 74b1503150 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.Manufacturing ((b)(4)) and quality inspection ((b)(4)) procedures and processes were reviewed and showed that proper controls are in place to guarantee that acceptable product is delivered to our customers.

Manufacturer Narrative

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

Event Description

The customer alleges that an air leak occurred because the adaptor didn't fit with the oxygen flow meter.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: ADAPTOR
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 8827 5; MX 88275
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 4898950
• MDR Text Key: 6064987
• Report Number: 3004365956-2015-00178
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 06/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/28/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74B1503150
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2015
• 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