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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT
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ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number SJ-05501
Device Problem Break (1069)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/23/2018
Event Type  Injury  
Manufacturer Narrative
(b)(4).The device investigation is pending.Teleflex will continue to monitor and trend related events.
 
Event Description
The epidural set was used for a woman in labor.When extracting the catheter it broke in the patient's back leaving about 5-6" in the back.The broken part was surgically removed and 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 broke in the patient during removal.The customer returned one snaplock adapter and one piece of an epidural catheter 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 the distal tip is not present on the returned catheter piece.The likely most distal end is severely stretched.The extrusion and the coil wire are stretched.The coil stretches approximately 37mm beyond the extrusion.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 (b)(4).A dimensional inspection was performed on the returned catheter piece using a ruler (c05158).The returned catheter extrusion measures approximately 100cm.The inner coils are stretched and extend approximately 37mm beyond the tip of the extrusion.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.However, the catheter tip is missing based on the condition of the sample received.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.6, 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." if further catheter resistance is encountered, the literature indicates "stretch catheter slightly and tape it to skin, creating constant tension on the catheter.As patient relaxes and moves, forces holding indwelling portion of catheter diminish and the constant tension on the catheter (created by stretching and taping) will facilitate retraction from the epidural space." 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 catheter breaking off during removal was confirmed based upon the sample received.The returned catheter was missing the distal tip.The catheter showed signs of significant stretching at the point of separation at the likely 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 stretching at the point of separation, operational context caused or contributed to this event.
 
Event Description
The epidural set was used for a woman in labor.When extracting the catheter it broke in the patient's back leaving about 5-6" in the back.The broken part was surgically removed and the patient's condition was reported as fine.
 
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Brand Name
EPIDURAL CATHETERIZATION KIT
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7694564
MDR Text Key114187771
Report Number1036844-2018-00191
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/25/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/17/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date11/30/2018
Device Catalogue NumberSJ-05501
Device Lot Number23F17K0443
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/05/2018
Date Manufacturer Received08/08/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
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