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

Catalog Number 403128

Device Problem Leak/Splash (1354)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/06/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two pictures were received for analysis.During the visual inspection, one of the pictures shows the subassembly p/n (b)(4) assembled with an aquapak sterile water bottle.The second picture shows the insert ((b)(4)) and can be observed the batch number (b)(4).No other issues were found.No functional inspection can be performed since the device sample is not available for evaluation.Failure mode could not be duplicated since it is unknown the reason for the adaptor leak.However, as an additional test, oxygen entrainment testing was performed to 30 subassembly (p/n: (b)(4)) production samples that were taken randomly from adaptors assembly line.These components are part of catalog number 30228 batch (b)(4).Catalog number 30228 uses the same subassembly (b)(4) than catalog number 403128 related to this customer complaint.During the testing and visual inspection no issues or discrepancies were found than can lead to the condition reported by the customer.As an additional test, one of the subassembly p/n (b)(4) production sample was assembled with a sterile water concha mini bottle and tested according oxygen entrainment testing.During the testing no issues or discrepancies were found that can lead to the condition reported by the customer.The device history record review did not show any issues or discrepancies which could potentially relate to this complaint.No conclusion can be established at this time based on the lack of the device sample.The physical sample is necessary in order to perform a proper investigation.If the device sample becomes available this complaint will be reopened.Customer complaint cannot be confirmed.However, the personnel from the assembly line were notified in order to keep the awareness of this type of issue.

Event Description

The customer alleges that the adaptor leaked.The patient's o2 saturation dropped despite increasing the oxygen.The nebulizer adaptor unit was replaced and the oxygen saturation increased.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the sample had signs of use and damage was found on the internal thread of the adaptor.Functional testing could not be performed due to the damage on the adaptor.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.Other remarks:.

Event Description

The customer alleges that the adaptor leaked.The patient's o2 saturation dropped despite increasing the oxygen.The nebulizer adaptor unit was replaced and the oxygen saturation increased.

• 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: 5233511
• MDR Text Key: 31522307
• Report Number: 3004365956-2015-00349
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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: 11/11/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 403128
• Device Lot Number: 74C1503424
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/03/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2015
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1