MAUDE Adverse Event Report: ANGIODYNAMICS PULSE SPRAY SYSTEM; INFUSION CATHETER

Catalog Number 12506417

Device Problems Fluid/Blood Leak (1250); Device Damaged Prior to Use (2284); Insufficient Information (3190)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 02/26/2016

Event Type  malfunction  

Manufacturer Narrative

The reported defect device has been returned to the manufacturer.An investigation into the root cause of this incident is currently in progress.The results of the investigation and any follow up information will be sent via a follow up medwatch.A review of the device history records was performed for the reported packaging and component lots for any deviations related to the reported defect of the complaint.The review confirms that the lots met all material, assembly, and performance specifications.(b)(4).

Event Description

As reported (b)(6) 2016, a patient of unknown age and gender presented for an unknown procedure.During preparation for the procedure, the treating physician attempted to aspirate liquid medicine into the 1cc syringe.The physician was unable to aspirate the medicine as it was noted that air was mixing with the medication inside of the syringe.The device was set aside and a new of the same device was used to successfully complete the procedure.There was no harm or injury to the patient as the device was not used for the procedure.The device has been returned to the manufacturer for evaluation.

Manufacturer Narrative

Returned for evaluation was a pulse spray 45f/45/5 pg catheter.The device was returned with the y-adapter and 1 cc syringe connected to the hub.A visual review of the catheter noted no obvious defects.The syringe was removed, filled with water and reconnected to the y-adapter.When an attempt was made to flush the device, water is seen leaking from the y-adapter.Upon closer examination and while physically manipulating the y-adapter, a crack is seen in the same area of the leak.The customer's reported complaint description of air mixing into the syringe is confirmed.The defect was found to be due to a fractured y-adapter.The y-adapter was sent to the vendor for evaluation.As stated by the vendor, the current warehouse raw materials and the assembly process were evaluated and neither yielded any evidence of a non-conformance.A root cause could not be determined by the vendor, although a possible factor could be due to overtightening of the female luer of the y-adapter and the mating male luer of the syringe to which it was connected.A review of the angiodynamics complaint system noted no trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.(b)(4).

• Brand Name: PULSE SPRAY SYSTEM
• Type of Device: INFUSION CATHETER
• Manufacturer (Section D): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer (Section G): ANGIODYNAMICS; 603 queensbury avenue; queensbury NY 12804
• Manufacturer Contact: law ryan ; 603 queensbury avenue; queensbury, NY 12804 ; 5187981215
• MDR Report Key: 5573385
• MDR Text Key: 42523313
• Report Number: 1319211-2016-00053
• Device Sequence Number: 1
• Product Code: KRA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905447
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 07/31/2017
• Device Catalogue Number: 12506417
• Device Lot Number: 4790443
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/22/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1