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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO

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TELEFLEX MEDICAL HUDSON VENTILATOR TUBING SET,LONG LENGTH CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Model Number IPN913687
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/01/2021
Event Type  malfunction  
Event Description
It was reported "i have had a few complaints over the last couple of weeks regarding our ventilator circuits (ref: 1613). The connector plugs become disconnected from the temperature probe ports". No patient injury or harm reported. Patient condition reported as "fine".
 
Manufacturer Narrative
Qn#: (b)(4). Complaint verification testing could not be performed as it was reported that the sample is not available for return. One photo of catalog number 1613 (ventilator tubing set, long length) lot 74d2001235 was received for analysis from the customer. It only shows a part of circuit where the wye p/n 12138-02 and closure p/n 30536) are located. 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.
 
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Brand NameHUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of DeviceCIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
Manufacturer (Section G)
TELEFLEX MEDICAL
parque industrial finsa
nuevo laredo 88275
MX 88275
Manufacturer Contact
marling heaton
3015 carrington mill blvd
morrisville 27560
MDR Report Key12921025
MDR Text Key281673509
Report Number3004365956-2021-00311
Device Sequence Number1
Product Code CAI
UDI-Device Identifier14026704658920
UDI-Public14026704658920
Combination Product (y/n)N
Reporter Country CodeCA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,User Facility,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 11/09/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model NumberIPN913687
Device Catalogue Number1613
Device Lot Number74D2001235
Was Device Available for Evaluation? No
Date Manufacturer Received11/09/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/10/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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