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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 SJ-05501
Device Problem Difficult to Remove (1528)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/17/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
The complaint states the patient had an epidural catheter placed on (b)(6) 2019 while in l & d.Upon attempt to remove it post-delivery, the catheter stretched despite attempts to change patient's position to allow removal.Determination was made to let swelling of area minimize and catheter was removed with tip intact later in the day.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural catheter with no relevant findings.The customer reported the catheter was difficult to remove.The customer returned one snaplock assembly, one epidural catheter, and lidstock.The returned sample was visually examined with and without magnification.Visual examination of the returned snaplock assembly revealed that the snaplock appears typical with no observed defects or anomalies.Visual examination of the returned catheter revealed the extrusion at the distal tip appears to be intact on the returned catheter.However, the extrusion and the coil wire are stretched at the distal end.The proximal side of the catheter appears to be intact as no damage was observed.The catheter appears to have been used as adhesive residue is present on the catheter body exterior.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 96.1cm.The extrusion and coils appear 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 kz-05400-002 rev.09.Specifications per graphic kz-05400-002 rev.8 were reviewed as a part of this complaint investigation.The ifu for this kit, e-17019-109a; rev.7, was reviewed as a part of this complaint investigation.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 the condition of the sample received indicates unintentional user error caused or contributed to this event.The reported complaint of the catheter being difficult to remove was confirmed based upon the sample received.The catheter showed signs of stretching at the distal end.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 the extrusion and coils stretching at the distal end, unintentional user error caused or contributed to this event.
 
Event Description
The complaint states the patient had an epidural catheter placed on (b)(6) 2019 while in l & d.Upon attempt to remove it post-delivery, the catheter stretched despite attempts to change patient's position to allow removal.Determination was made to let swelling of area minimize and catheter was removed with tip intact later in the day.
 
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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 Key8350331
MDR Text Key136532041
Report Number1036844-2019-00111
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 01/23/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2020
Device Catalogue NumberSJ-05501
Device Lot Number23F18G0475
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2019
Initial Date Manufacturer Received 01/23/2019
Initial Date FDA Received02/19/2019
Supplement Dates Manufacturer Received03/08/2019
Supplement Dates FDA Received03/13/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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