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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-05503-L
Device Problem Physical Resistance/Sticking (4012)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/06/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation.Teleflex will continue to monitor and trend related events.
 
Event Description
The report states that the doctor was using a glass lor to get a loss into the epidural space.It worked initially but then lor got stuck with saline in it.The plunger would not move either way.She had to pull lor out of the patient, open another kit, used new lor and was successful.Hopefully this is isolated.
 
Manufacturer Narrative
Qn#(b)(4).A device history record review was performed on the lor syringe with no relevant findings.The customer reported the lor syringe was not sliding.The customer returned one glass 5ml lor syringe and lidstock (reference files (b)(4)).The returned lor syringe was visually examined with and without magnification.Visual examination of the returned syringe appears typical with no defects or anomalies observed.Prior to decontamination, an attempt was made to slide the syringe plunger inside the barrel.The returned syringe plunger would slide but with resistance.The plunger would only slide to approximately the 1.7ml mark of the barrel.Visual examination of the plunger revealed a dried material at the bottom of the plunger.After decontamination and cleaning of the plunger, the dried material was gone (reference files (b)(4)).An attempt once again was made to slide the syringe plunger inside the barrel.The syringe plunger will slide in and out of the barrel with little resistance met.The movement in the syringe barrel feels typical.The returned syringe was functionally tested per pip-191 plunger movement test.A neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.The plunger was then released.The plunger fell freely to the bottom of the syringe barrel.The test was repeated twice, rotating the plunger 90 and 180 degrees.The plunger was able to freely fall each time.There were no functional issues found.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 lor syringe not sliding was confirmed based on the sample received.Prior to decontamination of the returned lor syringe, a dried material could be seen on the plunger preventing the plunger to fully insert into the barrel.After decontamination and cleaning of the plunger, the returned syringe performed typically and the syringe passed the plunger movement test per pip-191.There were no functional issues found with the returned syringe.Therefore, based upon the condition of the sample received and the observed dried material on the plunger, unintentional user error caused or contributed to this event.
 
Event Description
The report states that the doctor was using a glass lor to get a loss into the epidural space.It worked initially but then lor got stuck with saline in it.The plunger would not move either way.She had to pull lor out of the patient, open another kit, used new lor and was successful.Hopefully this is isolated.
 
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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 Key9491588
MDR Text Key184925718
Report Number1036844-2019-01091
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
Type of Report Initial,Followup
Report Date 12/16/2019
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 Date02/28/2021
Device Catalogue NumberAK-05503-L
Device Lot Number23F19J0431
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2019
Initial Date Manufacturer Received 12/16/2019
Initial Date FDA Received12/18/2019
Supplement Dates Manufacturer Received02/03/2020
Supplement Dates FDA Received02/06/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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