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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 No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/19/2020
Event Type  Injury  
Manufacturer Narrative
Qn#: (b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the catheter was inserted in the patient.But the doctor was not able inject the treatment.The doctor thought the catheter was misplaced, he tried again to inject the treatment but with no success.The catheter was removed.Outside the patient, an injection was tried on a gauze without success.A second catheter was used with success.Clinical consequence: 4 days after the incident the patient had a blood patch applied.The doctor supposed it was due to the incident with the 1st catheter.
 
Event Description
It was reported that the catheter was inserted in the patient.But the doctor was not able inject the treatment.The doctor thought the catheter was misplaced, he tried again to inject the treatment but with no success.The catheter was removed.Outside the patient, an injection was tried on a gauze without success.A second catheter was used with success.Clinical consequence: 4 days after the incident the patient had a blood patch applied.The doctor supposed it was due to the incident with the 1st catheter.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter would not inject medication.The customer returned one empty kit with one flat filter, one snaplock assembly, and an epidural catheter.The returned components were received connected together.The returned components were visually examined with and without magnification.Visual examination of the returned filter and snaplock assembly revealed both components appear typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the catheter appears used.Biological material can be seen between the inner coils.No other defects or anomalies were observed.A functional flow test was performed on the returned sample per (b)(4) section 7.8; rev.8.The returned epidural catheter was inserted from the proximal end into the returned snaplock assembly until it bottomed out and the snaplock assembly was closed.The components were confirmed to be secured by tugging gently.The snaplock assembly was connected to the lab leak tester (b)(4) and the pressure was increased to 10 psi to establish flow.Water could be seen immediately exiting the distal end of the catheter.The flow rate was measured at 7.8ml/min (stopwatch: (b)(4) ,which is within the specification of 1ml/min minimum.No blockages were found.A corrective action is not required at this time as there were no functional issues found with the returned sample.The reported complaint of the catheter not injecting medication could not be confirmed based on the sample received.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The returned components passed a functional flow test and met flow rate specifications.There were no functional issues found with the returned sample.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
MDR Report Key10960943
MDR Text Key219998436
Report Number3006425876-2020-01017
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 11/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/07/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/20/2022
Device Catalogue NumberJC-05400-B
Device Lot Number71F20F2332
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/30/2020
Date Manufacturer Received01/05/2021
Was Device Evaluated by Manufacturer? No
Date Device Manufactured06/30/2020
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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