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

Catalog Number 403128

Device Problem Connection Problem (2900)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Two pictures of fg 30228 adaptor,028 neb,non-ster,intl were received for analysis.During the visual inspection it was observed the sample in its original bag and the insert that shows the batch number 74j1501172.No other issues were found.A dimensional and functional inspection of the product involved in the complaint could not be conducted since the product was not returned.According to the batch number 74j1501172 provided by the customer the finished good is 30228 adaptor, 028 neb, non-ster, intl.The device history record of the product 30228 batch number 74j1501172 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.During the visual inspection of the pictures no issues or discrepancies were found than can lead to the condition reported by the customer.However, what the customer reports as "the hospital was not able to connect the flowmeter to the wall oxygen supply" is a similar issue reported on other customer complaints related to component p/n mp-0321.Regarding other customer complaints due to the same issue, a capa file (b)(4) was opened.Other remarks: 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.Customer complaint cannot be confirmed due to the lack of device 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.

Event Description

The customer alleges that they were unable to connect the adaptor to the flow meter.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the internal threads of the adaptor were damaged.The damage on the internal thread of the component was not acceptable according to current specifications.Functional testing was performed; however, the oxygen entrainment test could not be performed as the sample could not be connected correctly to the oxygen supply due to the damage on the internal thread.Based on the investigation performed, 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.Other remarks:.

Event Description

The customer alleges that they were unable to connect the adaptor to the flow meter.

• 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: 5497101
• MDR Text Key: 40244473
• Report Number: 3004365956-2016-00146
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 02/29/2016

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: No Information
• Device Catalogue Number: 403128
• Device Lot Number: 74J1501172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/26/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2016
• Initial Date FDA Received: 03/14/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/17/2016
• 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