MAUDE Adverse Event Report: EDWARDS LIFESCIENCES DR ANGIO KIT STANDARD; TRANSDUCER, PRESSURE, CATHETER TIP

Model Number CSA3009Z_

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/17/2014

Event Type  malfunction  

Manufacturer Narrative

Droplets were present on the inside of the housing.Silicone lubricant has been used in the inflation device for over 15 years to aid in the movement of the plunger along the length of the housing.Lubricant may be visible inside the housing to varying degrees.Nowhere in the manufacturing process is the device ever exposed to water or any other liquid, and there is no water present anywhere near the vicinity of the manufacturing process.Conclusions: the droplets may be formed from silicone lubricant that is used in the assembly of the inflation device, or from the unknown liquid introduced into the device by the end user.An exact metered amount of lubricant is used in every device to aid in plunger movement along the housing.Lubricant can atomize into droplets as show in a device receives an impact / shock to the system.This complaint is not confirmed.No corrective actions are necessary at this time.This complaint history will be recorded and used for trending purposes.This report concludes our investigation of the above listed complaint.The information generated or data accumulated will be filed for future reference, trends, or audits.We will continue to monitor and trend any problems associated with this device as we strive to continuously improve our products.

Manufacturer Narrative

Received one atrion inflation device with three-way stopcock.Unknown clear material was visible inside the wall of the barrel.Further evaluation is pending and a supplemental report will be submitted.

Event Description

It was reported that unknown liquid-like material was observed inside the syringe before use.There was no patient injury reported.

• Brand Name: ANGIO KIT STANDARD
• Type of Device: TRANSDUCER, PRESSURE, CATHETER TIP
• Manufacturer (Section D): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer (Section G): EDWARDS LIFESCIENCES DR; carretera sanchez, km 18 1/2; parque ind. de itabo,; haina. san cristobal ; DR
• Manufacturer Contact: lynn selawski ; 1 edwards way; irvine, CA 92614 ; 9497564386
• MDR Report Key: 3677970
• MDR Text Key: 11889241
• Report Number: 2015691-2014-00593
• Device Sequence Number: 1
• Product Code: DXO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K925638
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 02/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CSA3009Z_
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/24/2014
• Is the Reporter a Health Professional?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 02/18/2014
• Initial Date FDA Received: 03/13/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/16/2014
• 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: Initial
• Patient Sequence Number: 1