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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
Catalog Number 1613
Device Problem Fracture (1260)
Patient Problem No Patient Involvement (2645)
Event Date 04/15/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The sample was not returned; however, the customer provided a photo for evaluation.A visual exam was performed and it was observed there was a type of cut in the tubing.No other issues were observed.The device history record of batch number 74a1901330 has been reviewed and no issues or discrepancies were found which could potentially relate to this complaint.No non-conformance reports were originated for the lot in question that can be associated to the complaint reported.The dhr shows that the product was assembled and inspected according to specifications.The complaint is confirmed based on the photo, however, the actual sample is needed to conduct a proper investigation and to determine a root cause.If the sample is returned, a follow-up report will be submitted with investigation results.
 
Event Description
The complaint is reported as: "crack found in circuit prior to set-up during leak test.Clinician kept the circuit and will send back for investigation.No further information was provided." no patient harm or injury reported.
 
Event Description
The complaint is reported as: "crack found in circuit prior to set-up during leak test.Clinician kept the circuit and will send back for investigation.No further information was provided." no patient harm or injury reported.
 
Manufacturer Narrative
Qn#(b)(4).One (1) 1613 ventilator tubing set,long length was received for investigation.Upon receipt the tube set was visually inspected for any signs of abuse/misuse/damage.The complaint defect was pointed out with black marker.The defect is a "cut", or "slit" that runs approximately a 1/2 inch long parallel to one of the tube ridges.The complaint has been confirmed.However, a definitive root cause cannot be determined.The cut could have been the result of a box cutter when opening the shipping packaging/box.Or, the tubing could have come into contact with a sharp object in the clinical setting.The source of the cut cannot be confirmed.
 
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Brand Name
HUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of Device
CIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
research triangle park NC
MDR Report Key8591304
MDR Text Key144440132
Report Number3004365956-2019-00121
Device Sequence Number1
Product Code CAI
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/15/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number1613
Device Lot Number74A1901330
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/09/2019
Date Manufacturer Received05/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NOT REPORTED; NOT REPORTED; NOT REPORTED
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