MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC; NEBULIZER (DIRECT PATIENT INTE

Model Number IPN049299

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/28/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A picture and a video of catalog number 1883 was reviewed for visual analysis.During the visual inspection on the received picture & video, it is hard to appreciate the liquid as it is reported on this customer complaint therefore it is not possible to confirm this customer complaint as a manufacturing issue.Sample need to be evaluated to perform a proper investigation.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

It was reported that "when the customer assembled the nebulizer kit and prior to use on the patient, they found the liquid in the baffle jet".No patient involvement reported.

Manufacturer Narrative

Qn#(b)(4).The customer reported a liquid substance could be seen inside the jar of the nebulizer prior to use, and provided a photo and video that shows a clear liquid substance inside the jar.The customer returned one nebulizer kit which includes a jet, jar, cap, tubing, tee-connector and mouthpiece.The returned sample was visually examined with and without magnification.Visual examination of the returned sample revealed the returned components appear typical with no observed defects or anomalies.Microscopic examination of the returned sample did reveal any liquid substance inside the jar or on any of the returned components as the liquid substance most likely evaporated.Per the customer's request, the returned sample was sent for ftir analysis.According to the ftir analysis, the liquid that had been observed by the customer had evaporated by the time testing could be performed.However, a few "crystalline particles" could be seen on the interior surface of the returned nebulizer.Therefore, particles were removed for analysis.The analysis concluded "the clear liquid observed by the customer could not be definitively identified because the liquid had all evaporated prior to being received by the laboratory.However, salt crystals with traces of water were found on the interior surface of the complaint nebulizer.According to the manufacturing site, water is used during the extrusion process prior to assembly, however, the water does not make contact with the tubing and salt is not used during the process at all.The reported complaint of a liquid substance inside the jar of the nebulizer was confirmed based on a photo and video provided by the customer.The observed liquid substance had evaporated when the sample was received.Per the customer's request, an ftir analysis was performed on the returned sample.The analysis performed could not definitively identify the liquid substance observed by the customer based on the liquid being evaporated.However, salt crystals with traces of water were found on the interior surface.According to the manufacturing site, water used in the process does not contact the components during assembly and salt is not used at all.A device history record review was performed with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of this complaint could not be determined.

Event Description

It was reported that "when the customer assembled the nebulizer kit and prior to use on the patient, they found the liquid in the baffle jet".No patient involvement reported.

• Brand Name: HUDSON MICRO MIST NEBULIZER W/TEE,TBG & MTHPC
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 11342957
• MDR Text Key: 232367788
• Report Number: 3004365956-2021-00037
• Device Sequence Number: 1
• Product Code: CAF
• UDI-Device Identifier: 14026704627155
• UDI-Public: 14026704627155
• Combination Product (y/n): N
• PMA/PMN Number: K930525
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Type of Report: Initial,Followup
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: IPN049299
• Device Catalogue Number: 1883
• Device Lot Number: 74H1902394
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2021
• Date Manufacturer Received: 03/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: N/A.