MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON AQUAPAK 700 SW,760 ML,JAPAN; NEBULIZER (DIRECT PATIENT INTE

Catalog Number 037-00J

Device Problem Break (1069)

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

Event Date 08/16/2021

Event Type  malfunction  

Manufacturer Narrative

Qn# (b)(4).

Event Description

It was reported that "the connecting part to the flowmeter got broken during use.Therefore, aquapack was replaced with a new unit".No patient injury or harm reported.Patient condition reported as "fine".

Manufacturer Narrative

Qn#(b)(4).The sample was returned and sent to the manufacturer for investigation.The manufacturer reports: one empty 760 ml water bottle, lot 21f015, was received for evaluation.The adaptor port was punctured.The bottle has a crack along the neck of the bottle.This crack is identified as a neck crack, a criteria for inspection of product code 037-00j.A review of the manufacturing event log shows no issues that may have contributed to any quality issues reported.All process parameters were within specification and all in process qa inspections were acceptable.Based on the information provided, the complaint is confirmed.The root cause was determined to be manufacturing related.A non-conformance was opened to further address this issue.

Event Description

It was reported that "the connecting part to the flowmeter got broken during use.Therefore, aquapack was replaced with a new unit".No patient injury or harm reported.Patient condition reported as "fine".

• Brand Name: HUDSON AQUAPAK 700 SW,760 ML,JAPAN
• Type of Device: NEBULIZER (DIRECT PATIENT INTE
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• MDR Report Key: 12461425
• MDR Text Key: 271079049
• Report Number: 1417411-2021-00018
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• PMA/PMN Number: K141214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 037-00J
• Device Lot Number: 21F015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Date Manufacturer Received: 10/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: FLOWMETER; FLOWMETER; FLOWMETER