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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

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

Event Date 09/15/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional or dimensional inspection of the product involved in the complaint could not be conducted since the product or a picture of the defect was not provided.Additional test, oxygen entrainment testing (tp-0041) was performed to 30 subassembly (p/n: 12161) production samples that were taken randomly from adaptors assembly line.These components are part of catalog number 30228 batch# (b)(4).During the testing no issues or discrepancies were found than can lead to the condition reported by the customer.The device history record for the reported lot# was reviewed and no issues or discrepancies were found that could potentially relate to this complaint.No non-conformance reports were originated for reported lot#.Customer complaint cannot be confirmed due to the lack of device sample to perform a proper investigation and determine the root cause.If the sample becomes available this investigation will be updated with the evaluation results.A capa file #(b)(4) was opened to perform a further investigation of this issue.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.

Event Description

The customer alleges that the flow volume connector had an unstable connection.No patient injury reported.

Manufacturer Narrative

Qn#(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 detected that the internal threads of the adaptor were damaged.It was not possible to perform the oxygen entrainment testing as the adaptor could not be connected correctly on the oxygen supply due to the damage on the internal thread.Based on the visual exam, the reported complaint was confirmed.The root cause for the issue is 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 the flow volume connector had an unstable connection.No patient injury reported.

• 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: 5123779
• MDR Text Key: 27336145
• Report Number: 3004365956-2015-00306
• 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
• Remedial Action: Other
• Type of Report: Followup
• Report Date: 09/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/28/2020
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1503092
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/02/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/23/2015
• 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