MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON ADAPTOR,028 NEB,INTL; NEBULIZER (DIRECT PATIENT INTERFACE)

Catalog Number 403128

Device Problems Disconnection (1171); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/11/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

Customer complaint alleges "the screw fitting that is connected to the oxygen dispenser does not hold, is detached and does not supply oxygen." alleged issue reported as occurred during patient use.There was no report of patient harm.No report of necessary medical intervention.Patient condition reported as "fine".

Manufacturer Narrative

(b)(4).The sample was returned for evaluation.A visual exam was performed and it was observed that the puncture pin protector was missing.It was also observed that the adaptor did not spin freely.The sample was tested on general pull and push test procedures with no functional issues; however, due the unstable condition on the assembly of the nut adaptor and the upper body it was not possible to perform the dual station lift test and the oxygen entrainment test.The adaptor was carefully disassembled from the upper body and visually inspected.During the visual inspection it was observed that the internal tabs were bent.Based on the additional inspection of the adaptor, the complaint is confirmed.However, it is unknown how the internal tabs of the adaptor were damaged.It is possible it occurred when the end user connected the adaptor to the flowmeter.There is not sufficient evidence to assure that this issue was originated during the manufacturing assembly or molding process.Personnel of the assembly line were notified on (b)(6) 2018 for awareness.

Event Description

Customer complaint alleges "the screw fitting that is connected to the oxygen dispenser does not hold, is detached and does not supply oxygen." alleged issue reported as occurred during pateint use.There was no report of patient harm.No report of necessary medical intervention.Patient condition reported as "fine".

• Brand Name: HUDSON ADAPTOR,028 NEB,INTL
• Type of Device: NEBULIZER (DIRECT PATIENT INTERFACE)
• Manufacturer (Section D): TELEFLEX MEDICAL; research triangle park NC
• MDR Report Key: 7689666
• MDR Text Key: 114029464
• Report Number: 3004365956-2018-00223
• Device Sequence Number: 1
• Product Code: CAF
• Combination Product (y/n): N
• 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: 06/21/2018

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 Expiration Date: 07/27/2022
• Device Catalogue Number: 403128
• Device Lot Number: 74G1701587
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2018
• Initial Date Manufacturer Received: 06/21/2018
• Initial Date FDA Received: 07/16/2018
• Supplement Dates Manufacturer Received: 08/03/2018
• Supplement Dates FDA Received: 08/08/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: OXYGEN DISPENSER; OXYGEN DISPENSER; OXYGEN DISPENSER