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

Catalog Number OU-05500-J

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2016

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

When flushing the lor syringe before use, some black materials came out from the syringe.The physician did not use the kit.There was no patient harm.

Manufacturer Narrative

(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.The returned sample was visually examined with and without magnification.Visual examination of the returned syringe revealed that the syringe was wrapped in parafilm, reference attached files (b)(4).Microscopic examination revealed that there were black particulates found on the bottom of the barrel closest to the tip.Black particulate was also found near the teflon ring and particulate was found on the barrel of the syringe.Nonconformance, (b)(4), have been imitated 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.Microscopic examination revealed that there were black particulates found on the bottom of the barrel other remarks: closest to the tip.Black particulate was also found near the teflon ring and particulate was found on the barrel of the 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, (b)(4), has been initiated to further investigate this issue.

Event Description

When flushing the lor syringe before use, some black materials came out from the syringe.The physician did not use the kit.There was no patient harm.

• 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: 6169025
• MDR Text Key: 62199892
• Report Number: 3006425876-2016-00387
• 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: 11/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2016
• 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: 12/12/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/03/2017
• 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