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 08/12/2016

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

The syringe does not provide immediate resistance when it should and it is not easy to use for detecting loss of resistance.The patient's condition was reported as unknown.

Manufacturer Narrative

(b)(4).A device history record review could not be performed as no product code or lot number was provided.Visual inspection could not be performed as no sample was returned for analysis.A photo of the device was returned for analysis.However, the complaint could not be confirmed based upon the photo received.A corrective action is not required at this time as the potential cause of difficulty finding loss of resistance 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 could not be performed as no product code or lot number was provided.Therefore, the potential cause of difficulty finding loss of resistance could not be determined based upon the information provided and without a sample.

Event Description

The syringe does not provide immediate resistance when it should and it is not easy to use for detecting loss of resistance.The patient's condition was reported as 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: 5933296
• MDR Text Key: 54652883
• Report Number: 1036844-2016-00490
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 08/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/07/2016
• 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: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/11/2016
• 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