MAUDE Adverse Event Report: MEDTRONIC PUERTO RICO OPERATIONS CO. ASCENDA; PUMP, INFUSION, IMPLANTED, PROGRAMMABLE

Model Number 8780

Device Problem Contamination (1120)

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

Event Date 04/30/2019

Event Type  malfunction  

Manufacturer Narrative

Product analysis #(b)(4): analysis information -- 2019-09-10 13:35:00 cst pli# 10 product id# 8780 below is unedited, system generated text based on the analysis finding code(s).The returned device was subjected to a series of standard tests that include but is not limited to visual inspection, patency testing, and pressure testing.Visual inspection identified a broken seal in the sterile package.The device history report (dhr) was reviewed and there were {no} anomalies in the manufacturing processes of the device.Analysis determined the inner tray of the sterile packaging did not properly hold the components in place.The pump was returned, and analysis found the inner tray did no properly hold the components in place and the sterile seal was compromised.If information is provided in the future, a supplemental report will be issued.

Event Description

Information was received from a manufacture representative (rep) regarding a patient that was receiving unknown drug via an implanted pump.It was reported that when the provider opened the catheter packaging to use for a procedure the catheter popped out of the packaging.The event date was noted as (b)(6) 2019.When the rep looked at the packaging they noticed that the catheter was not correctly seated inside of the packaging.The rep did not use the catheter because they felt that because it had popped out of the package when they opened it that it was not sterile.They used a different catheter instead and will be returning the catheter that popped out of the packaging.It was noted the issue was resolved.

• Brand Name: ASCENDA
• Type of Device: PUMP, INFUSION, IMPLANTED, PROGRAMMABLE
• Manufacturer (Section D): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer (Section G): MEDTRONIC PUERTO RICO OPERATIONS CO.; road 31, km. 24, hm 4; ceiba norte industrial park; juncos PR 00777
• Manufacturer Contact: lisa woodward clark ; 7000 central avenue ne rcw215; minneapolis, MN 55432 ; 7635263920
• MDR Report Key: 9013921
• MDR Text Key: 158110605
• Report Number: 3004209178-2019-17537
• Device Sequence Number: 1
• Product Code: LKK
• UDI-Device Identifier: 00763000051112
• UDI-Public: 00763000051112
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P860004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2019
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/27/2021
• Device Model Number: 8780
• Device Catalogue Number: 8780
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2019
• Date Manufacturer Received: 09/10/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2019
• 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