MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 031-33J

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved in this complaint was not returned for evaluation by the manufacturer.A photo was submitted with the complaint.Visual inspection of the picture submitted, shows an adaptor attached to a water bottle.Also, the adaptor is connected into a flowmeter that has an unstable condition on the assembly of the nut adaptor component p/n tfx-001743 and the upper body component p/n mp-0527.No other issues were found.A functional inspection of the product involved in the complaint could not be conducted since the product was not provided.A dhr review could not be conducted since the lot number was not provided.Customer complaint is confirmed based on the picture provided.However, based on this investigation, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly process.(cont.) other remarks: it is unknown how the adaptor assembly got unstable when the end user connected the adaptor to the flowmeter.It is necessary to have the physical sample in order to perform a proper and thorough investigation to determine a root cause.If the device sample becomes available this report will be updated.

Event Description

Customer complaint alleges "the connection between the adaptor and the flowmeter was too loose to be fastened; when connecting to flowmeter, the ring of the connection part wavered.Therefore, a new unit was used instead." no patient involvement reported.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: linda woodall ; 3015 carrington mill blvd; morrisville 27560 ; 9196942566
• MDR Report Key: 7764115
• MDR Text Key: 116478742
• Report Number: 3004365956-2018-00240
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/02/2018

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: 031-33J
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2018
• Initial Date FDA Received: 08/08/2018
• 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
• Treatment: FLOW METER