MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. MEDICAL UNKNOWN DUMMY MATERIAL

Catalog Number MEDICAL UNKNOWN

Device Problem Physical Resistance (2578)

Patient Problem No Information (3190)

Event Date 10/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device is unavailable for investigation.The manufacturer will continue to monitor and trend related events.

Event Description

Wet tap during epidural placement.The loss of resistance glass syringe in the provided epidural kit stuck during the procedure causing inadvertent dural puncture.The patient's condition is unknown.

Manufacturer Narrative

(b)(4).The device is unavailable for investigation.The manufacturer will continue to monitor and trend related events.A corrective action is not required at this time as a potential cause could not be determined based upon the information provided and without a sample.Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed on the lor syringe with no evidence to suggest a manufacturing related cause.Therefore, the potential cause of the lor syringe becoming stuck could not be determined based upon the information provided and without a sample.

Event Description

Wet tap during epidural placement.The loss of resistance glass syringe in the provided epidural kit stuck during the procedure causing inadvertent dural puncture.The patient's condition is unknown.

• Brand Name: MEDICAL UNKNOWN DUMMY MATERIAL
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 312 commerce place; asheboro NC 27203
• Manufacturer Contact: jasmine brown ; 3015 carrington mill blvd; morrisville, NC 27560 ; 9193614124
• MDR Report Key: 6147198
• MDR Text Key: 61871218
• Report Number: 1036844-2016-00574
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: MEDICAL UNKNOWN
• Device Lot Number: 23F15H0820
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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