MAUDE Adverse Event Report: HUDSON NEONATE DUAL HEATED DUAL DRAIN; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913843
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be conducted since the lot number of the device was not provided.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 or Problem Description
It was reported the "circuit became disconnected at the cup".No patient harm or injury reported.Patient condition reported as "stable on room air".Device was replaced.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 880-15kit, neonate dual heated dual drain for investigation.Visual examination revealed the circuit was disconnected at the iso-gard reservoir drain, as reported by the customer.Due to the disconnection, the heated wire cable came out of the corrugated tubing.Evidence of adhesive residue was observed on the corrugated tubing on both sides of the iso-gard reservoir drain where the circuit was disconnected.A dent was also observed on the corrugated tubing towards the interface between the tubing and iso-gard reservoir drain.Microscopic examination of the corrugated tubing and iso-gard reservoir drain revealed a substantial amount of adhesive used for this joint.It appears that the circuit was taped during use.If the circuit was taped at the locations where the adhesive was observed and the ventilator or incubator were moved while connected to the circuit, this would magnify the forces on the iso-gard reservoir drain and corrugated tubing joint.However, based on the amount of adhesive observed on the returned sample, it's unlikely that the joint would break even under such force.The reported complaint is confirmed; however the root cause could not be established.It was determined this was an isolated issue.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported the "circuit became disconnected at the cup".No patient harm or injury reported.Patient condition reported as "stable on room air".Device was replaced.

• Brand Name: HUDSON NEONATE DUAL HEATED DUAL DRAIN
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11613345
• Report Number: 3004365956-2021-00132
• Device Sequence Number: 14202835
• Product Code: OGG
• UDI-Device Identifier: 14026704660510
• UDI-Public: 14026704660510
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/17/2021

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
• Operator of Device: No Information
• Device Model Number: IPN913843
• Device Catalogue Number: 880-15KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2021
• Initial Date Received by Manufacturer: 03/17/2021
• Supplement Date Received by Manufacturer: 05/05/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 05/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.