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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 OU-05500-J
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/08/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). The device has not been returned for investigation at this time. The manufacturer will continue to monitor and trend related events.
 
Event Description
It was reported that after a procedure the physician found black materials floating on saline in the medicine cup. The physician had no idea when the saline had been contaminated. The physician did not use the 20ml or the 3ml syringe, instead used the lor 5ml syringe during the procedure. There were no additional attempts as the procedure was completed. There was no reported delay, death, or complications to the patient as a result of this occurrence. Additional information indicated the physician did not see any black material in the medicine cup during the epidural catheter insertion. The lor syringe, containing 3-4ml of saline, was placed in the medicine cup after it was initially removed from the catheter. The black material was observed when the lor syringe was later obtained from the cup to check backflow. The syringe was not used any further.
 
Manufacturer Narrative
Qn#(b)(4). A device history record review was performed on the kit, lor syringe, and medicine cup with no relevant findings. The customer reported seeing black particulates in the medicine cup after using a glass lor syringe. The customer returned one glass lor syringe and one medicine cup ((b)(4)). The customer also returned one photo of the medicine cup filled with liquid with visible black particles floating on the surface, (b)(4). The returned sample was visually examined with and without magnification. Visual examination of the returned medicine cup revealed black particulates on the surface. The particulates varied in size. Visual examination of the returned syringe revealed the syringe tip has a film (such as tape) covering the outer surface. Blemishes can also be seen on the metal tip. Microscopic examination of inside the barrel of the lor syringe from the top to the tip reveals a black discoloration at the tip as compared to a new lab inventory syringe which does not appear to have a black discoloration ((b)(4)). It cannot be determined if the discoloration is on the inside surface of the barrel at the tip or the outside where the tip is adhered to the glass surface. No black particulates. Other remarks: were found on the outside or inside surface of the syringe barrel or on the surface of the plunger. No other defects or anomalies were observed. Nonconformance, 40008371, have been initiated to further investigate this complaint issue. The reported complaint of black particulates on the medicine cup after flushing the lor syringe was confirmed based on the sample received. Visual examination of the returned sample revealed particulates on the surface of the returned medicine cup. Visual examination of the returned glass lor syringe revealed a film covering on the metal tip as well as blemishes. No particulates were found on the surface area of the syringe plunger or barrel. However, microscopic examination of the inside the barrel of the lor syringe from the top to the tip did reveal a black discoloration at the tip as compared to a new lab inventory syringe. A device history record review was performed on the kit, lor syringe, and medicine cup with no evidence to indicate a manufacturing related issue. The lor syringe is a purchased part. Therefore, the potential root cause of this issue is supplier related. A nonconformance, 40008371, has been initiated to further investigate this issue.
 
Event Description
It was reported that after a procedure the physician found black materials floating on saline in the medicine cup. The physician had no idea when the saline had been contaminated. The physician did not use the 20ml or the 3ml syringe, instead used the lor 5ml syringe during the procedure. There were no additional attempts as the procedure was completed. There was no reported delay, death, or complications to the patient as a result of this occurrence. Additional information indicated the physician did not see any black material in the medicine cup during the epidural catheter insertion. The lor syringe, containing 3-4ml of saline, was placed in the medicine cup after it was initially removed from the catheter. The black material was observed when the lor syringe was later obtained from the cup to check backflow. The syringe was not used any further.
 
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Brand NameEPIDURAL CATHETERIZATION KIT
Type of DeviceANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL CR, A.S.
jamska 2359/47
zdar nad sazavou 591 0 1
EZ 591 01
Manufacturer Contact
jasmine brown
3015 carrington mill blvd
morrisville, NC 27560
9193614124
MDR Report Key6138394
MDR Text Key61296177
Report Number3006425876-2016-00374
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
Reporter Country CodeJA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/01/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? No
Device Operator
Device Expiration Date09/30/2017
Device Catalogue NumberOU-05500-J
Device Lot Number71F16A0480
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/28/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/15/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured01/06/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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