MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER W/TEE,MTHPC & TBG, SMALL VOLU

Catalog Number 41892

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A visual, functional and dimensional inspection of the product involved in the complaint could not be conducted since the product was not returned.The device history record (dhr) of batch number 74g1402407, product code 41892 has been reviewed and no issues or discrepancies were found related to this complaint.Dhr shows that the product was assembled & inspected according to our specifications.A corrective action cannot be applied since it is not possible to identify the defect reported and to investigate its root cause, in order to perform a proper investigation it is necessary to evaluate the sample involved in the incident.Customer complaint cannot be confirmed based only on the information provided.If device sample becomes available at a later date this complaint will be re-opened.

Event Description

The customer alleges that the upper part of the nebulizer doesn't fit to the connector.

Manufacturer Narrative

Qn#(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that it had the wrong cap.The product code 41892 should have the cap part number 12054 (cap, micromist w/22mm id modified); however, the sample received was assembled with the cap part number 12154 (cap, micro mist nebulizer).The customer complaint is confirmed based on the sample received.It was detected that the wrong component was used in the manufacturing process of the product.Regarding this issue, capa request # 15-018 has been generated in order to investigate the root cause of the issue and establish a corrective action in order to avoid recurrence of the defect.In addition, a notification of the complaint and re-training was given to the personnel involved in the manufacturing process of the product in order to make them aware of this issue.

Event Description

The customer alleges that the upper part of the nebulizer doesn't fit to the connector.

Manufacturer Narrative

Qn#(b)(4).The device history record of batch number 74g1402407 was reviewed and it was noticed that non-conformance #60023803 was issued to the batch of this complaint.The non-conformance defect is due to a wrong component that was used in the manufacturing process of product pn 41892 (nebulizer w/tee,mthpc & tbg, small volume) and based on the visual inspection performed to the sample sent by the customer the non-conformance can be related to the failure mode reported by the customer.

Event Description

The customer alleges that the upper part of the nebulizer doesn't fit to the connector.

• Brand Name: HUDSON NEBULIZER W/TEE,MTHPC & TBG, SMALL VOLU
• 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: 5144202
• MDR Text Key: 28037104
• Report Number: 3004365956-2015-00309
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: SZ
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Followup,Followup
• Report Date: 09/29/2015

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: 41892
• Device Lot Number: 74G1402407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/21/2015
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/12/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 11/20/2015; 11/24/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/23/2014
• 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