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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number JC-05400-B
Device Problem Material Puncture/Hole (1504)
Patient Problem Pain (1994)
Event Date 09/05/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that the catheter has a hole.The treatment injection went out of the catheter at the level after the filter.Medical intervention: we cut the catheter before the hole and performed immediate analgesia after repair.Clinical consequences: pain when the patient woke up.
 
Event Description
It was reported that the catheter has a hole.The treatment injection went out of the catheter at the level after the filter.Medical intervention: we cut the catheter before the hole and performed immediate analgesia after repair.Clinical consequences: pain when the patient woke up.
 
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 has a hole.The customer returned one catheter piece (reference attached files (b)(4)).The returned catheter piece was visually examined with and without magnification.Visual examination of the returned catheter piece revealed the proximal end was returned as the proximal tip is still intact.The likely most distal end appears to have cut.Also, there appears to be damage to the extrusion and coil wire approximately 5mm from the likely distal end (reference files (b)(4)).Specifications per graphic kz-05400-002 rev.9 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-110a; rev.2, was reviewed as a part of this complaint investigation.The ifu cautions the user, "do not alter the catheter or any other kit/set component during insertion, use or removal (except as instructed)." a corrective action is not required at this time as the investigation shows no evidence to suggest a manufacturing related cause.All epidural catheters are tested for leaks at the time of manufacturing.A device history record review performed on the epidural catheter showed no evidence to suggest a manufacturing related cause.The hole was detected during use.Therefore, based on the condition of the sample received and the time of discovery indicate operational context caused or contributed to this event.The reported complaint of epidural catheter having a hole was confirmed based upon the sample received.The customer returned one catheter piece measuring approximately 5.1cm.The returned catheter piece appears to have been cut and was damaged near the likely most distal end.The ifu for this product cautions the user not alter the catheter.All epidural catheters are 100% tested for leaks at the time of manufacturing.A device history record review was performed on the epidural catheter with no evidence to suggest a manufacturing related issue.The hole was detected during use.Therefore, based on the time of discovery and the condition of the sample received, unintentional user error caused or contributed to this event.
 
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Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9244569
MDR Text Key167005876
Report Number3006425876-2019-00789
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,u
Type of Report Initial,Followup
Report Date 10/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/26/2020
Device Catalogue NumberJC-05400-B
Device Lot Number71F18L0360
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2019
Date Manufacturer Received11/21/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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