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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 Loose or Intermittent Connection (1371)
Patient Problem No Patient Involvement (2645)
Event Date 09/14/2020
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.The device history record of batch number 74e2000290 that belongs to catalog number 1613 has been reviewed and no issues or discrepancies were found which could potentially be related 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.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 Description
The complaint is reported as: "the customer has been using the 1613 and 1605 for many years.Recently , they figured out that the 1605 does not fit as snuggly in the 1613 circuit.It is pretty loose and tends to fall out." the customer is concerned that something has changed with the circuit.It was reported the product was not in use during a medical procedure, and there was no patient complication or injury.
 
Manufacturer Narrative
Qn# (b)(4).The customer returned one sample of 1613 breathing circuit with bacterial filter.A visual exam was performed and no defects or anomalies were observed.A 22mm plug and ring gauge test was performed on the circuit and filter to check the dimensional requirements per iso-5356-1:2015 anesthetic and respiratory equipment - conical connectors - part 1: cones and sockets.A force gauge was used to apply 50 +/- 5 n of axial force to a 22mm fixture connected to the part under test.Results confirmed that all parts were within specifications.The filter was connected and disconnected to the breathing circuit and no significant differences were observed in the tightness of the connection.The reported complaint of a loose connection could not be confirmed.The sample passed all relevant visual, dimensional and functional testing.A device history record review was performed with no evidence to suggest a manufacturing related cause.Since all of the returned components were within specification, no defects were observed with the returned sample.Teleflex will continue to monitor and trend on complaints of this nature.
 
Event Description
The complaint is reported as: "the customer has been using the 1613 and 1605 for many years.Recently , they figured out that the 1605 does not fit as snuggly in the 1613 circuit.It is pretty loose and tends to fall out." the customer is concerned that something has changed with the circuit.It was reported the product was not in use during a medical procedure and there was no patient complication or injury.
 
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Brand Name
HUDSON VENTILATOR TUBING SET,LONG LENGTH
Type of Device
CIRCUIT, BREATHING (W CONNECTO
Manufacturer (Section D)
TELEFLEX MEDICAL
morrisville NC
MDR Report Key10621380
MDR Text Key209628207
Report Number3004365956-2020-00196
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,user f
Type of Report Initial,Followup
Report Date 09/17/2020
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
Device Operator No Information
Device Catalogue Number1613
Device Lot Number74E2000290
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/13/2020
Initial Date Manufacturer Received 09/17/2020
Initial Date FDA Received10/02/2020
Supplement Dates Manufacturer Received11/03/2020
Supplement Dates FDA Received11/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
TELEFLEX BACTERIAL/VIRAL FILTER, PRODUCT CODE 1605; TELEFLEX BACTERIAL/VIRAL FILTER, PRODUCT CODE 1605; TELEFLEX BACTERIAL/VIRAL FILTER, PRODUCT CODE 1605
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