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

Catalog Number 031-33J

Device Problem Failure to Deliver (2338)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/26/2016

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.No photo available for review.A device history record review could not be conducted since the lot number was not provided.No corrective action can be established since lot number was not provided and sample is not available to perform an investigation and determine the source of defect reported.Customer complaint cannot be confirmed due to the lack of sample and since no lot number was provided for investigation.An attempt to duplicate the failure mode was made but at the time there is no inventory of the involved product code available at the facility and it is not being manufactured at the time.If the device sample becomes available this compliant will be reopened.The personnel of the assembly line will be notified for awareness.

Event Description

The customer alleges that oxygen and humidification were not delivered to the patient.The patient's condition is reported as good and no additional therapy was needed.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample was used.It was also received without the puncture pin protector.No other issues were found.Functional testing was performed and there were no issues detected.Based on the investigation performed, the reported complaint could not be confirmed.There were no issues found with the returned sample.

Event Description

The customer alleges that oxygen and humidification were not delivered to the patient.The patient's condition is reported as good and no additional therapy was needed.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER
• 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: 5722588
• MDR Text Key: 47303734
• Report Number: 3004365956-2016-00243
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

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: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/02/2016
• Initial Date FDA Received: 06/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/21/2016
• 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: Unknown
• Patient Sequence Number: 1