MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DIREXION; CATHETER, CONTINUOUS FLUSH

Model Number 80618

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/23/2019

Event Type  malfunction  

Event Description

It was reported that the device had foreign matter inside the packaging.A direxion catheter was unpacked out of the box.When the item was removed from the outer box, it was observed that there was moisture in the packaging.It was observed that the box had soaked up some fluid, but when the catheter was removed, moisture was also observed within the inner sterile packaging.The device was not used with a patient.

• Brand Name: DIREXION
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road,; cork ; EI
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8620274
• MDR Text Key: 145390637
• Report Number: 2134265-2019-05426
• Device Sequence Number: 1
• Product Code: KRA
• UDI-Device Identifier: 08714729839354
• UDI-Public: 08714729839354
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K142259
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/17/2019

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 Expiration Date: 12/05/2020
• Device Model Number: 80618
• Device Catalogue Number: 80618
• Device Lot Number: 0023041331
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/29/2019
• Initial Date FDA Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/06/2018
• 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