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

Catalog Number 031-33J

Device Problem Connection Problem (2900)

Patient Problem No Patient Involvement (2645)

Event Date 09/02/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.

Event Description

The complaint was reported as: it was reported that, before use on a patient, the user found it difficult to connect the adaptor to the flowmeter, as he/she had to put more power to rotate it than usual.Therefore, a new unit was used instead.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.While performing the visual inspection it was observed that the nut adaptor doesn't spin freely, probably due to an incorrect use of the device when threading the adapter in the flowmeter.No other issues were found.The sample was tested on the oxygen entrainment test and during the setup it was observed that the assembly of the nut adaptor component and the upper body component was unstable.Even with that condition, the sample was able to be tested on oxygen entrainment testing with no functional issues.After the testing was finished, the nut adaptor was carefully disassembled from the upper body and it was visually inspected.During the visual inspection it was found wear on its internal tabs.Based on the investigation of the returned sample, the complaint is confirmed.Although the complaint is confirmed, there is not enough evidence to assure that this issue was originated during the manufacturing assembly or molding process.The wear on the internal tabs of the adaptor was most likely caused by the end user during the connection of the adaptor into the flowmeter, although this could not be confirmed.

Event Description

The complaint was reported as: it was reported that, before use on a patient, the user found it difficult to connect the adaptor to the flowmeter, as he/she had to put more power to rotate it than usual.Therefore, a new unit was used instead.

• Brand Name: HUDSON NEBULIZER ADAPTOR 033,STERILE,JAPANESE
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 10543473
• MDR Text Key: 207334523
• Report Number: 3004365956-2020-00179
• 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: 09/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2020
• 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: 74H1900578
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/05/2020
• Date Manufacturer Received: 11/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1