MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION KIT; ANESTHESIA CONDUCTION KIT

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.

• Brand Name: EPIDURAL CATHETERIZATION KIT
• Type of Device: ANESTHESIA 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 Key: 6138394
• MDR Text Key: 61296177
• Report Number: 3006425876-2016-00374
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: OU-05500-J
• Device Lot Number: 71F16A0480
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/06/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1