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

Catalog Number 031-28

Device Problems Break (1069); No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2016

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.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed due to the lack of product sample to perform a proper investigation and determine the root cause.If the device sample becomes available this investigation will be updated with the evaluation results.However, a capa file #(b)(4) was opened to perform a further investigation into this issue (this capa is owned by (b)(4)).According to the capa investigation so far the root cause for the issue was the positioning of the thread lead and the softness of the new resin used for the snap adaptor.Additionally, the personnel of the assembly line were notified and made aware of this issue.

Event Description

The customer alleges that there was no oxygen flow from the t-piece.The bottom of the wing nut broke and failed to support that contact of the gland into the seat of the connector.No patient harm reported.

Manufacturer Narrative

(b)(4).One unit of subassembly (b)(4) adaptor phantom holder was received for analysis.A dual station lift test and general pull and push test procedures were performed.It was not possible to perform the oxygen entrainment testing as the adaptor had damage on the internal locks that caused an incorrect connection to the oxygen supply.Based on the visual exam, the reported complaint was confirmed.The root cause for the issue was found to be the positioning of the thread lead and the softness of the new resin used for the snap adaptor.A capa was opened to address this issue.

Event Description

The customer alleges that there was no oxygen flow from the t-piece.The bottom of the wing nut broke and failed to support that contact of the gland into the seat of the connector.No patient harm reported.

• 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: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9194334854
• MDR Report Key: 5415953
• MDR Text Key: 37716776
• Report Number: 3004365956-2016-00120
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 01/28/2016

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: Health Professional
• Device Catalogue Number: 031-28
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2016
• Initial Date FDA Received: 02/08/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/24/2016
• 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: Initial
• Patient Sequence Number: 1