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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/06/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that on the (b)(6) 2020 during use, the screw thread of the filter broke.Consequence: the filter separated, so there was a risk of infection.The epidural catheter had to be replaced.It happened few times already.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the flat filter with no relevant findings.The customer reported the rotatable collar detached from the filter.The customer returned one snaplock assembly, one flat filter, and one catheter piece approximately 12cm.The components were received connected together; however, the rotation collar is actually not intact to the male lock connector (reference attached files (b)(4)).The returned components were visually examined with and without magnification.Visual exanimation of the returned snaplock assembly revealed the snaplock appears typical with no observed defects or anomalies.Visual inspection of the returned filter revealed the filter was received with the rotation collar detached from the filter.Microscopic examination of the male lock connection showed the lip that holds the collar in place is tapered which can allow the collar to be removed easier.The customer also provided photos that show the collar detached from the male lock connector.Functional testing was performed on the returned sample.The rotating collar was reattached to the male lock connector of the returned filter.Using hand pressure, the rotating collar could be removed from the male lock connector with little effort.This was also attempted on a lab inventory filter.Using hand pressure, the rotating collar could not be removed even with much effort.Again, using hand pressure, the returned filter was connected to the returned snaplock assembly.Upon hand tightening the rotating collar, the collar detached from the male lock connector and remained attached to the female connector of the snaplock.The same test was performed using a lab inventory filter with the returned snaplock with no issues.The reported complaint of the rotating collar being detached from the filter was confirmed based on the sample received.Visual inspection of the returned filter revealed the rotating collar was detached from the male lock connector.Microscopic inspection revealed the lip that holds the collar was tapered which can allow the collar to be removed easier.Functional testing performed on the returned sample revealed the rotating collar can be detected from the male lock connector with hand pressure, where a lab inventory filter's collar could not be removed even with much effort.Also, when connecting the returned filter to the returned snaplock assembly, the collar would detach from the male lock connector when hand tightening.A device history record review was performed on the flat filter with no relevant findings.However, based on the functional testing of the returned sample, the potential root cause of this issue is supplier related.A scar was initiated to further investigate this complaint issue.
 
Event Description
It was reported that on the (b)(6) 2020 during use, the screw thread of the filter broke.Consequence: the filter separated, so there was a risk of infection.The epidural catheter had to be replaced.It happened few times already.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10580536
MDR Text Key208346959
Report Number3006425876-2020-00828
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,health professional
Type of Report Initial,Followup
Report Date 09/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/24/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/02/2022
Device Catalogue NumberJC-05400-B
Device Lot Number71F20F0913
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/17/2020
Date Manufacturer Received10/23/2020
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/12/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
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