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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 KIT

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ARROW INTERNATIONAL INC. SPINAL ANES/EPIDURAL CATH KIT ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number ASK-05560-OM1
Device Problem Material Protrusion/Extrusion (2979)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/15/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device investigation report has not been submitted at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
Anesthesia noticed at first that it was hard to push medication through the end of the catheter. When the epidural was discontinued the wire was protruding through the end of the catheter. The entire device was removed. The patient's condition was reported as fine.
 
Manufacturer Narrative
(b)(4). A device history record review was performed on the epidural catheter with no relevant findings. The customer reported the catheter coil wire was protruding at the distal tip when the catheter was being removed from the patient. The customer returned one snaplock adapter, one epidural catheter and one non-teleflex syringe for investigation. The components were received connected together (reference attached files (b)(4)). The returned sample was visually examined with and without magnification. Visual examination of the returned snaplock adapter revealed that the snaplock appears typical with no observed defects or anomalies. Visual examination of the returned catheter revealed catheter appears used. The distal end shows signs of stretching and coil wire appears to be stretched and the extrusion is damaged, but the distal tip is intact. The coil wire is stretched beyond the catheter extrusion tip. The proximal side of the catheter appears to be intact as no damage was observed. No other defects or anomalies were observed (reference (b)(4)). A dimensional inspection was performed on the returned catheter using a ruler ((b)(6)). The returned catheter extrusion measures approximately other remarks: 120cm. The inner coils are stretched and extend approximately 1. 5cm beyond the tip of the extrusion. The extrusion appears to be stretched at the distal end of the catheter. This is why the catheter is well beyond outside of the specification of 88. 5-91. 5 cm per graphic (b)(4). No part of the catheter appears to be missing. Specifications per graphic (b)(4) were reviewed as a part of this complaint investigation. The ifu for this product, (b)(4), was also reviewed as a part of this complaint investigation. The ifu contains catheter removal instructions with a list of warnings including, "never tug or quickly pull on catheter during removal from patient to reduce risk of breakage. Do not apply additional tension on the catheter if catheter begins to stretch excessively. During epidural catheter removal, the literature indicates a force of approximately 1/3 of a pound is all that is necessary to exert if patient is properly positioned in the recommended lateral neutral position. " the ifu also provides alternate catheter removal techniques if difficulty is encountered and indicates "since any epidural catheter can inadvertently be separated if excessive force is applied during removal , clinicians must be aware of the importance of proper removal technique. " a corrective action is not required at this time as the condition of the sample received indicates operational context caused or contributed to this event. The reported complaint of the coil wire protruding at the tip was confirmed based upon the sample received. The distal end of the returned catheter was intact, however, there were signs of stretching and the coil wire was stretched beyond the extrusion. The ifu for this product warns the user not to apply additional tension if the catheter begins to stretch as there is a risk for separation. Therefore , based upon the condition of the sample received and the observed evidence of stretching at the distal end, operational context caused or contributed to this event.
 
Event Description
Anesthesia noticed at first that it was hard to push medication through the end of the catheter. When the epidural was discontinued the wire was protruding through the end of the catheter. The entire device was removed. The patient's condition was reported as fine.
 
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Brand NameSPINAL ANES/EPIDURAL CATH KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
312 commerce place
asheboro NC 27203
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6152491
MDR Text Key61716866
Report Number1036844-2016-00625
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/07/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date03/31/2018
Device Catalogue NumberASK-05560-OM1
Device Lot Number23F16J0531
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/21/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/05/2017
Was Device Evaluated by Manufacturer? No
Date Device Manufactured09/29/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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