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

Catalog Number 031-33J

Device Problem Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2020

Event Type  malfunction  

Manufacturer Narrative

Qn# (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

Customer reported the return tube came off from the bottle during use.The adaptor was replaced.No patient harm or delay in treatment reported.

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that there was a loose connection between the tubing and the puncture pin.The tip of the tubing was visually inspected and it was observed there was adhesive residue along its surface as well as outside the connection side of puncture pin.The tubing was cut on 3 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 two sections were measured at the molding department (internal component supplier) and the internal diameter of all sections are within dimensional specifications.The puncture pin was also measured at the molding department and the external diameter is within dimensional specifications.Functional test could not be performed due to the loose connection between the tubing and the puncture pin.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 complaint is confirmed, there is not sufficient evidence to assure that this issue was originated during the manufacturing assembly.It is unknown how the adaptor was handled during use.This is considered to be an isolated event.

Event Description

Customer reported the return tube came off from the bottle during use.The adaptor was replaced.No patient harm or delay in treatment 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: 9770762
• MDR Text Key: 198095681
• Report Number: 3004365956-2020-00055
• 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: 02/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2020
• 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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 04/03/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NONE REPORTED.; NONE REPORTED.