MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADDIPAK FNS 5ML; NEBULIZER

Catalog Number V200-59

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 10/05/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The customer supplied one photograph.The photograph of the addipak vials is out of focus, the investigator cannot discern any issue related to mixed product codes in the box.A sample will be required for complaint investigation.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record review showed no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections shows two non-conformances that have no bearing on the quality issue reported.Non-conforming material was sorted for a defect, re-inspected, and found to be acceptable per internal specification.No sample available from the customer to investigate.Complaint not confirmed.Root cause unknown.Teleflex will continue to monitor feedback from the customers on issues related to mixed product codes in the box on water bottle products.

Event Description

The customer alleges that there is an inaccurate content of fluid in the vial.No patient injury or harm reported.

Manufacturer Narrative

(b)(4).A review of the manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification.All in-process qa inspections show two non-conformances that may have a bearing on the quality issue reported.Non-conforming material was sorted for a defect, re-inspected, and found to be acceptable per internal specification.The customer provided a defective sample of the product involved in the complaint.The sample contained vials that were less than the stated 5.0 ml volume.Based on the visual exam, the reported complaint was confirmed.Further investigation and corrective action to be taken per (b)(4).

Event Description

The customer alleges that there is an inaccurate content of fluid in the vial.No patient injury or harm reported.

• Brand Name: HUDSON ADDIPAK FNS 5ML
• Type of Device: NEBULIZER
• 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: 5165410
• MDR Text Key: 28825968
• Report Number: 1417411-2015-00166
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 10/08/2015

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: No Information
• Device Expiration Date: 05/31/2017
• Device Catalogue Number: V200-59
• Device Lot Number: 04E15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/21/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/08/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2015
• 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