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

Model Number	IPN913836
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Respiratory Problem (4464)
Date of Event	03/26/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 connection at the clear connector that goes on the column becomes disconnected very easily, either by hand or on the column.This incident happened one time.This incident for this complaint was a detachment and it effected the patient, causing them to code, but it turned out that they intubated the patient and the patient is now fine and has come off the ventilator".No patient injury or harm reported.Patient condition reported as "fine".
Event or Problem Description
It was reported "the connection at the clear connector that goes on the column becomes disconnected very easily, either by hand or on the column.This incident happened one time.This incident for this complaint was a detachment and it effected the patient, causing them to code, but it turned out that they intubated the patient and the patient is now fine and has come off the ventilator".No patient injury or harm reported.Patient condition reported as "fine".
Additional Manufacturer Narrative
(b)(4).The customer provided one video displaying them easily removing the blue circuit tubing from the elbow connector.The customer also returned one 870-19kit set for evaluation.Visual inspection of the tubing did not reveal any defects or anomalies.The tubing was returned fully assembled to its connector.The inner diameter of the circuit connection that would slide over the elbow connector was measured to be 0.851", which is not within specifications of 0.827-0.847" per circuit product drawing.The outer diameter of the elbow connector was measured to be 0.86985" which is within specifications of 0.8622-0.8701" per circuit product drawing.The returned tubing was removed from its connector with minimal force.The complaint was confirmed.The sample was sent to the manufacturing site for further investigation.The manufacturing site reports that the corrugated tube can be easily disconnected from the connector as it is described in the customer complaint.Also, it was noted that the resistance wire was cut in the teleflex laboratory in o rder to perform a proper dimensional inspection test.The diameter of the connector and corrugated tubing that were easily disconnected were verified and it was found that the diameter of the corrugated tube is out of dimensional specification.Ten samples from cu rrent inventory at the manufacturing facility were dimensionally inspected and no issues were found.The samples were found to be within specification.Based on investigation of the returned sample, the complaint has been confirmed.The circuit tubing did not meet the dimensional spe cifications and was able to be easily removed from the elbow connector.Although the returned sample was found to be out of specification, this could not be confirmed as a manufacturing issue since received sample was found manipulated and it is not possible to as sure that issue was generated during the manufacturing process.The root cause of this complaint could not be determined.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: 11679712
• Report Number: 3003898360-2021-00389
• Device Sequence Number: 11640733
• Product Code: OGG
• UDI-Device Identifier: 14026704660398
• UDI-Public: 14026704660398
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 03/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: No Information
• Device Expiration Date: 12/16/2025
• Device Model Number: IPN913836
• Device Catalogue Number: 870-19KIT
• Device Lot Number: 74A2100245
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/28/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/28/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/04/2021
• 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
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention