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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER
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ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05560
Device Problems Material Separation (1562); Difficult to Advance (2920)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/12/2018
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 it was difficult to thread the epidural catheter.The tuohy needle was turned 90 degrees and another attempt was made to thread, but increased resistance was met when attempting to remove the catheter and the needle together.After removal it appeared that the needle tip had sheared off.The needle was not bent.A second attempt with a braun epidural kit was successful.
 
Manufacturer Narrative
Qn# (b)(4).A device history record review was performed on the epidural catheter and needle with no relevant findings.The customer reported the catheter was difficult to remove from the patient.The customer returned one epidural catheter and lidstock for investigation (reference files inp1900065270).The returned catheter was visually examined with and without magnification.Visual examination of the returned catheter revealed part of the distal tip appears to be missing (reference files anp1900065270).The catheter appears to have been used as biological material can be seen on the inner coil wire.No other defects or anomalies were observed.A dimensional inspection was performed on the returned catheter using a ruler (ga-ln-0560-003).The returned catheter extrusion measures approximately 91.6cm.The extrusion and coils may be slightly stretched , and this is why the catheter is beyond outside of the specification of 88.5-91.5 cm per graphic kz-05400-002 rev.09.The outer diameter (od) of the returned catheter measured 1.03mm (caliper c05155) which is within the specification of a maximum of 1.115mm per graphic kz-05400-002; rev 9.Although, part of the distal tip was missing, an attempt to thread the returned epidural catheter was made.The distal end of the catheter would thread through a lab inventory 17ga needle with no resistance met.A drag test was performed per pip-013, rev.3 using the returned catheter, a lab inventory needle and weight (c05406).The catheter passed the drag test with the lab inventory needle.Specifications per graphic kz-05400-002 rev.9 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.07, was reviewed as a part of this complaint investigation.The ifu warns the end user, "never advance catheter more than 5 cm beyond the needle tip.Advancing catheter more than 5 cm increases the likelihood of catheter-related complications." the ifu warns the user, "never tug or quickly pull on catheter during removal from patient to reduce risk of catheter breakage.Do not apply additional tension on the catheter if catheter begins to stretch excessively.Reposition patient to open the vertebral interspaces and re-attempt removal if resistance is encountered or if catheter stretches excessively during removal." the reported complaint of the catheter being difficult to remove was confirmed based upon the sample received.Microscopic examination revealed part of the distal tip was missing.The returned epidural catheter could be thread through a 17ga lab inventory needle with no resistance met.The returned catheter also passed a functional drag test, and the returned catheter od was found to be within specification.A device history record review was performed on the epidural catheter and needle with no relevant findings.The catheter is an interactive part.Therefore, based upon the condition of the sample received and the observed evidence of the part of the distal tip missing, operational context caused or contributed to this event.
 
Event Description
It was reported that it was difficult to thread the epidural catheter.The tuohy needle was turned 90 degrees and another attempt was made to thread, but increased resistance was met when attempting to remove the catheter and the needle together.After removal it appeared that the needle tip had sheared off.The needle was not bent.A second attempt with a braun epidural kit was successful.
 
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Brand Name
SPINAL ANES/EPIDURAL CATH KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8212207
MDR Text Key131911588
Report Number1036844-2019-00008
Device Sequence Number1
Product Code BSO
Combination Product (y/n)N
PMA/PMN Number
K140110
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 12/13/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/03/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date09/30/2019
Device Catalogue NumberAK-05560
Device Lot Number23F18J0176
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/03/2019
Date Manufacturer Received01/28/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age34 YR
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