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 01/23/2020

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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

Complaint reported as: "it was reported that the user found the connecting part assembly was loose and air was leaking from there before use on a patient.He/she touched it, then it easily got detached.Therefore, a new unit was used instead." no patient involvement reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.Signs of use were observed since the sample was not received in the original package and a loose connection on the nebulizer assembly was found.The involved components in the loose connection are the tubing supply disconnected from the nebulizer base.The tip of the tubing was visually inspected and adhesive residues were observed along the surface as well inside the connection side of base.The tubing was cut into 4 sections.The section of the tubing that was disconnected from the base was discarded to be measured because this section had adhesive residues.The other three sections were measured at the molding department (internal component supplier) and the external diameter of all sections are within dimensional specifications (0.376" +/- 0.005").The base was also measured at the molding department and the internal diameter is within dimensional specification (0.371" +/- 0.005").Based on the visual inspection of the sample received, the complaint is confirmed as a disconnection issue since while performing the visual inspection test a tubing disconnection issue was observed.Although the condition observed on the sample provided, there is no sufficient evidence to assure that this issue was originated during the manufacturing assembly.A root cause could not be established.

Event Description

Complaint reported as: "it was reported that the user found the connecting part assembly was loose and air was leaking from there before use on a patient.He/she touched it, then it easily got detached.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; morrisville NC
• MDR Report Key: 9699918
• MDR Text Key: 198509445
• Report Number: 3004365956-2020-00036
• 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: 01/24/2020

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2020
• Initial Date Manufacturer Received: 01/24/2020
• Initial Date FDA Received: 02/12/2020
• Supplement Dates Manufacturer Received: 03/11/2020
• Supplement Dates FDA Received: 03/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.