MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 028,SHELFPAK

Catalog Number 031-28

Device Problem Connection Problem (2900)

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

Event Date 11/03/2015

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 functional inspection can be performed since the device sample is not available for evaluation.However, as an additional test, production samples of subassembly p/n 12153 that were taken randomly from adaptors assembly line were assembled onto a concha mini sterile water bottle.These components are part of product (b)(4) batch 74l1501326.The component p/n 10842 nebulizer base, 028 is part of the product (b)(4) and the product 031-28 and it is related to this customer complaint.During the assembly, the component p/n 10842 was screwed correctly onto a concha mini sterile water bottle.No other issues or discrepancies were found than can lead to the condition reported by the customer.A device history record review could not be conducted since the lot number was not provided.No conclusion can be established at this time based on the lack of device sample.If the device sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.

Event Description

The customer alleges that the adaptor would not screw onto the water bottle evenly.

• Brand Name: HUDSON NEBULIZER ADAPTOR 028,SHELFPAK
• 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: margie burton, rn ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334965
• MDR Report Key: 5258038
• MDR Text Key: 32409003
• Report Number: 3004365956-2015-00354
• 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: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/17/2015

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: Lay User/Patient
• Device Catalogue Number: 031-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 11/17/2015
• Initial Date FDA Received: 12/01/2015
• 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