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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO
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HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT; CIRCUIT, BREATHING (W CONNECTO Back to Search Results
Model Number IPN049872
Device Problem Connection Problem (2900)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/30/2021
Event Type  malfunction  
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 Description
It was reported that, "before use on a patient, the user was unable to connect the connector to the patient-side device because it was too hard.Therefore, a new unit was used instead".No patient involvement reported.
 
Event Description
It was reported that, "before use on a patient, the user was unable to connect the connector to the patient-side device because it was too hard.Therefore, a new unit was used instead".No patient involvement reported.
 
Manufacturer Narrative
(b)(4).One unit of catalog number 7140 (breathing circuit, anesthesia, adult) was received for analysis.The et tube was not returned and the size of the et tube used was not reported.After the inner diameter of the elbow connector was measured, an attempt to measure the inner diameter of the wye connector was made.However, it was very difficult to remove the elbow connector from the wye connector.After extreme force was exerted, the elbow was able to be disconnected from the wye.There appears to be adhesive residue on the connectors.Dimensional inspection was performed by measuring the inner diameter of the elbow connector of the returned circuit.The inner diameter was found to be within specification when measured with a 15mm connector gauge per iso 5361.The inner diameter of the wye connector was also measured.The inner diameter was found to be within specification when measured with a 15mm connector gauge.R and d was consulted.Per r and d there is evidence that the elbow and wye connectors were bonded to each other.The manufacturing site was consulted.Per the manufacturing site, the elbow connector is assembled inside the wye connector without solvent.Therefore, both components can be separated.The sample was sent to the manufacturing site for further investigation.The manufacturing site reports that a visual exam was performed and it was observed that there were marks on the connectors.Such marks could be adhesive residue.It was also reported that as an additional test, connector components (elbow and wye connector) were taken from the production line.Two groups of samples were built.The first group of samples were assembled using pip.As a result, the elbow connector could not be detached from the wye connector.Extreme force was applied in order to disconnect them.It was also observed that there was adhesive residue on the components but in more quantity compared to the customer sample.The second group of samples were assembled per work instruction (without solvent) then a drop of pip was applied on the joint of both components.As result, the elbow connector could not be detached from the wye connector.Force was applied (less than the above samples) to disconnect them.It was observed that adhesive residue was on the components, similar to the complaint sample.Based on the investigation performed the reported complaint was confirmed.A non-conformance was opened to address this issue.
 
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Brand Name
HUDSON BREATHING CIRC,ANES,ADULT, 48 IN W/3 LT
Type of Device
CIRCUIT, BREATHING (W CONNECTO
MDR Report Key12380995
MDR Text Key268713929
Report Number3004365956-2021-00263
Device Sequence Number1
Product Code CAI
UDI-Device Identifier14026704641410
UDI-Public14026704641410
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 08/06/2021
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
Device Operator No Information
Device Model NumberIPN049872
Device Catalogue Number7140
Device Lot Number74G2000248
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/24/2021
Initial Date Manufacturer Received 08/06/2021
Initial Date FDA Received08/27/2021
Supplement Dates Manufacturer Received10/06/2021
Supplement Dates FDA Received10/07/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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