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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 Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 06/26/2018
Event Type  malfunction  
Manufacturer Narrative
Qn#: (b)(4). The device has not been returned for investigation. Teleflex will continue to monitor and trend related events.
 
Event Description
It was reported that there is more resistance or imperfections with the lor syringe. Either the glass syringe or the plunger is getting caught up with the other.
 
Manufacturer Narrative
(b)(4). No lot number was provided. A device history record review was performed based upon a lot number from sales history data. A device history record review was performed on the lor syringe with no relevant findings. The customer reported more resistance is felt when inserting the plunger into the barrel of an lor syringe. The customer returned one glass 5ml lor syringe (reference attached 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 not slide. After decontamination of the returned syringe, an attempt once again to slide the syringe plunger inside the barrel was performed. 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 A neoprene sleeve was placed on the plunger to prevent breakage and the plunger was retracted out of the barrel to the 5ml marker.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 there were no functional issues found with the returned lor syringe. The reported complaint of the syringe feels to have more resistance than normal could not be confirmed based on the sample received. 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.
 
Event Description
It was reported that there is more resistance or imperfections with the lor syringe. Either the glass syringe or the plunger is getting caught up with the other.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7704394
MDR Text Key114546338
Report Number1036844-2018-00211
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 06/28/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberSJ-05501
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/18/2018
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

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