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

Catalog Number 031-33J

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 12/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device involved has not been received by the manufacturer for evaluation at the time of this report.A device history record review could not be conducted since the lot number was not provided.Customer complaint cannot be confirmed.Root cause cannot be determined.No corrective action can be established at this time.If the sample becomes available this report will be updated with the evaluation results.

Event Description

Customer complaint alleges "the snap-on connector of the adaptor easily detached from the adaptor when the user manually pulled the adaptor lightly." no patient involvement reported.

Manufacturer Narrative

(b)(4).One (1) unit of catalog number 031-33j (nebulizer adaptor 033, sterile, japanese) was received for analysis.During the visual inspection it was observed that the nut was missing.No other issues were found.It was not possible to perform functional testing because the nut is missing; therefore, it could not be connected on the flowmeter of the oxygen tank.The complaint could not be confirmed since during the visual inspection it was observed that the nut was missing on this returned product.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specification.Teleflex will continue to track and trend this failure mode.

Event Description

Customer complaint alleges "the snap-on connector of the adaptor easily detached from the adaptor when the user manually pulled the adaptor lightly." 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
• MDR Report Key: 8174070
• MDR Text Key: 130771549
• Report Number: 3004365956-2018-00367
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K153010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 03/18/2023
• Device Catalogue Number: 031-33J
• Device Lot Number: 74C1801113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2019
• Date Manufacturer Received: 01/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.