• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05503
Device Problem Break (1069)
Patient Problems Pain (1994); No Consequences Or Impact To Patient (2199)
Event Date 11/30/2019
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
Received via medwatch# (b)(4).Epidural catheter placed by anesthesiologist; he notes: "positioned sitting upright, approach midline, needle (#17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10 cm; catheter inserted into epidural space: 3 cm; insertion level: l2-3,".About 6 hours later, the patient delivered her baby vaginally.Post-delivery the nurse tried to remove the catheter and met resistance, so she stopped.She called the charge rn who repositioned the patient, then attempted to pull out the catheter, but also met resistance and stopped.The crna was called.He attempted and when he pulled the catheter, it snapped/broke.At that point, the anesthesiologist was notified.He could see a bit of the catheter poking out under the skin, so he numbed the area and attempted to grasp the end of it from under the skin.
 
Manufacturer Narrative
Qn#: (b)(4).A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no relevant findings.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, "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." a corrective action is not required at this time as a potential root cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.The customer did provide photos that show a broken catheter.However, a sample is needed to determine a possible root cause.A lot number was not provided.A device history record review was performed based upon a lot number from sales history data.A device history record review was performed on the epidural catheter with no evidence to indicate a manufacturing related issue.Therefore, the potential cause of the catheter breaking could not be determined based upon the information provided and without a sample.
 
Event Description
Received via medwatch#: (b)(4).Epidural catheter placed by anesthesiologist; he notes: "positioned sitting upright, approach midline, needle (#17 gauge, placed via loss of resistance technique (saline), depth of epidural space: 7cm; catheter depth at skin: 10 cm; catheter inserted into epidural space: 3 cm; insertion level: l2-3,".About 6 hours later, the patient delivered her baby vaginally.Post-delivery the nurse tried to remove the catheter and met resistance, so she stopped.She called the charge rn who repositioned the patient, then attempted to pull out the catheter, but also met resistance and stopped.The crna was called.He attempted and when he pulled the catheter, it snapped/broke.At that point, the anesthesiologist was notified.He could see a bit of the catheter poking out under the skin, so he numbed the area and attempted to grasp the end of it from under the skin.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key9569279
MDR Text Key174308048
Report Number1036844-2020-00017
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 health professional,other,use
Type of Report Initial,Followup
Report Date 01/06/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAK-05503
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 01/06/2020
Initial Date FDA Received01/09/2020
Supplement Dates Manufacturer Received02/20/2020
Supplement Dates FDA Received02/21/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
N/A.
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age32 YR
Patient Weight94
-
-