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

Model Number	IPN913836
Medical Device Problem Code	Melted (1385)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A visual inspection of the product involved in the complaint was performed on three pictures received by the customer of product code 870-19kit (conchasmart 22mm sgl htd limb circ kit).It can be observed that the corrugated tubing was melted as described.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 melted".Unknown at time of report where issue was observed.Unknown patient condition at time of report.
Event or Problem Description
It was reported "the circuit melted".Unknown at time of report where issue was observed.Unknown patient condition at time of report.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned three photos for evaluation.The first two photos revealed a 870-19kit circuit that had severely been melted and the third photo revealed the circuit within its packaging.The customer also returned the heated wire circuit of an 870-19kit.Upon receipt, the sample was visually inspected.The unit was severely melted in one section where the circuit separated and many other minor melts were found.The large melt was about 5.5" from the connector.The melt was approximately 5" long.The plastic of the heated wires in this section were found melted together.Melted sections were also found between 28.5-32.5" and 33-35" from the connector.Additional melted sections were found between 4-7.5" and 10-11" from the separation point in the circuit.Exposed wire was noted on the 3.5" section.The resistance of the circuit was measured to be 13.5 ohms, which is within specification of 12.8-14.3 ohms.The ifu 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: CONCHASMART 22MM SGL HTD LIMB CIRC KIT
• Common Device Name: HUMIDIFIER NEBULIZER KIT
• MDR Report Key: 11952413
• Report Number: 3004365956-2021-00191
• Device Sequence Number: 4015539
• Product Code: OGG
• UDI-Device Identifier: 14026704660398
• UDI-Public: 14026704660398
• Combination Product (Y/N): N
• Initial Reporter State: OK
• 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): 05/17/2021

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: IPN913836
• Device Catalogue Number: 870-19KIT
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/01/2021
• Initial Date Received by Manufacturer: 05/17/2021
• Supplement Date Received by Manufacturer: 06/25/2021
• Initial Report FDA Received Date: 06/07/2021
• Supplement Report FDA Received Date: 06/25/2021
• 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