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 10/29/2013

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Three pictures were received for analysis.During the visual inspection, two pictures show the subassembly p/n (b)(4) assembled with an (b)(6) sterile water bottle and connected to the oxygen supply.One picture show only the subassembly p/n (b)(4) connected to the oxygen supply.On the 3 pictures it can be observed that the component p/n (b)(4) cannot be connected correctly on the oxygen supply.No other issues were found.No functional inspection can be performed since the device sample is not available for evaluation.However, as an additional test, oxygen entrainment testing ((b)(4)) was performed to (b)(4) 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).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.Other remarks: during the testing no issues or discrepancies were found that can lead to the condition reported by the customer.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.During the visual inspection on the pictures received it can be observed that the component p/n (b)(4) cannot be connected correctly on the oxygen supply, therefore, customer complaint is confirmed.Regarding other customer complaints due to the same issue, a capa file #(b)(4) was opened to perform a further investigation this issue (this capa is owned by (b)(6)).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 in order to keep them aware of this issue.

Event Description

The customer alleges that the adaptor would not attach to the flowmeter.

Manufacturer Narrative

(b)(4).

Event Description

The customer alleges that the adaptor would not attach to 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: 5229227
• MDR Text Key: 31336661
• Report Number: 3004365956-2015-00351
• 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: company representative,foreig
• Reporter Occupation: Nurse
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2015
• 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: 74C1503625
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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