MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER

Catalog Number 403128

Device Problem Connection Problem (2900)

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

Event Date 11/01/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.No photo available.No functional inspection can be performed since the device sample is not available for evaluation.However as an 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 product 30228 batch (b)(4).The component p/n mp-0321 is part of subassembly (b)(4) and is related to this customer complaint.During the testing no issues or discrepancies were found than can lead to the condition reported by the customer.Based on the batch number provided by the customer, the finished good number is 30228.The device history record of the product 30228 batch number (b)(4) has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No nonconformance reports were originated for the lot in question that can be associated to the complaint reported.Dhr shows that the product was assembled and inspected according to our specifications.Other remarks: customer complaint cannot be confirmed due to the lack of product 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.However, based on complaint trend due to similar issues, a capa file #(b)(4) was opened to perform a further investigation 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.Additionally, the personnel of the assembly line were notified.

Event Description

The customer alleges that the adaptor does not fit properly to the flowmeter.It is difficult to screw onto the flowmeter.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the device was in the original packaging and had no signs of use.The sample had no issues or discrepancies found that could lead to the condition reported by the customer.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 device.

Event Description

The customer alleges that the adaptor does not fit properly to the flowmeter.It is difficult to screw onto the flowmeter.

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• 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: 5266954
• MDR Text Key: 32670457
• Report Number: 3004365956-2015-00375
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 11/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/04/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 403128
• Device Lot Number: 74C1503064
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1