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U.S. Department of Health and Human Services

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

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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION CATHETER Back to Search Results
Catalog Number AK-05502
Device Problem Break (1069)
Patient Problem No Information (3190)
Event Date 01/15/2019
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
(b)(4).It was reported that a l & d patient had an epidural catheter.Upon attempt by md to remove it, the catheter broke at the 9 cm mark and was retained in her back.Ct scan revealed a 3 cm epidural fragment retained in the epidural space.Patient then had surgical removal of the epidural fragment.The patient's condition is unknown at this time.
 
Event Description
Medwatch (b)(4).It was reported that a l & d patient had an epidural catheter.Upon attempt by md to remove it, the catheter broke at the 9 cm mark and was retained in her back.Ct scan revealed a 3 cm epidural fragment retained in the epidural space.Patient then had surgical removal of the epidural fragment.The patient's condition is unknown at this time.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review could not be performed as no lot number was provided by the customer.A review of sales history data was performed to obtain a lot number.However, no record could be found.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 device history records were not reviewed as no lot number was provided by the customer and no sales history records could be found.Therefore, the potential cause of the catheter tip breaking could not be determined based upon the information provided and without a sample.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION CATHETER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key8388095
MDR Text Key137788644
Report Number1036844-2019-00180
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 other
Type of Report Initial,Followup
Report Date 02/12/2019
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-05502
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 02/12/2019
Initial Date FDA Received03/04/2019
Supplement Dates Manufacturer Received04/01/2019
Supplement Dates FDA Received04/02/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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