MAUDE Adverse Event Report: HUDSON 22MM SGL HTD LIMB CIRC KIT; HUMIDIFIER NEBULIZER KIT

Model Number	IPN913836
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
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 was performed and no relevant findings were identified.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 melted, close to the patient end.The patient was on hfnc during the day.The rn touched the circuit and realized it was really hot.At this time the patient was on bipap for the evening and not on the hfnc.They discovered that they had turned the flow off on the hfnc but had not turned the heater off.The patient was not wearing the the set up, so it was not "during use on patient"".No patient involvement reported.
Event or Problem Description
It was reported "the circuit melted, close to the patient end.The patient was on hfnc during the day.The rn touched the circuit and realized it was really hot.At this time the patient was on bipap for the evening and not on the hfnc.They discovered that they had turned the flow off on the hfnc but had not turned the heater off.The patient was not wearing the set up, so it was not "during use on patient"".No patient involvement reported.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one 870-19kit kit containing a circuit, extra tubing, column, temp probes, and nasal breathing device.Visual inspection of the circuit revealed there was severe melting.Parts of the heated wire cable were melted through the circuit.White residue was also found melted to part of the circuit.The melted portion of the circuit measured 4-20" from the open end connector.The resistance across the heated wire measured 13.7 ohms which is within specification of 12.8-14.3 ohms.The ifu for this product states, "do not place tubing on patient's skin.Do not cover tubing with sheets, blankets, towels, clothing, or other materials." the complaint of a breathing circuit melting has been confirmed.Since all heated wire circuit product codes are inspected 100% before leaving the manufacturing facility, it is unlikely that the failure was present at the time of release.A device history record review was performed with no evidence to suggest a manufacturing related issue.The root cause for the failure is unintentional user error.Teleflex will continue to monitor and trend on complaints of this nature.

• Brand Name: HUDSON 22MM SGL HTD LIMB CIRC KIT
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 12091727
• Report Number: 3004365956-2021-00201
• Device Sequence Number: 17125054
• Product Code: OGG
• UDI-Device Identifier: 14026704660398
• UDI-Public: 14026704660398
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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): 06/11/2021

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: Health Professional
• Device Model Number: IPN913836
• Device Catalogue Number: 870-19KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/22/2021
• Initial Date Received by Manufacturer: 06/11/2021
• Supplement Date Received by Manufacturer: 07/22/2021
• Initial Report FDA Received Date: 06/30/2021
• Supplement Report FDA Received Date: 07/23/2021
• 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: HEATER; HEATER; HEATER