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

Model Number	8578
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
Information was received from a health care provider (hcp) via a device manufacturer representative regarding a catheter revision kit.It was reported that the physician and circulating nurse said there were not any "clear boots" in the kit (assumed to mean strain relief shrouds).A new kit was given and the issue was resolved.The kit was going to be returned to the manufacturer.No patient involvement was noted.No further complications were reported.
Additional Manufacturer Narrative
Analysis of the sutureless catheter connector kit (b)(4) found that a component was missing from the packaging.If information is provided in the future, a supplemental report will be issued.

• Common Device Name: 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
• MDR Report Key: 7325000
• Report Number: 3004209178-2018-04704
• Device Sequence Number: 120350
• Product Code: LKK
• UDI-Device Identifier: 00643169887633
• UDI-Public: 00643169887633
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P860004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/01/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 06/15/2019
• Device Model Number: 8578
• Device Catalogue Number: 8578
• Device Lot Number: HG1WK4Z08
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/13/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2018
• Supplement Date Received by Manufacturer: 04/30/2018
• Initial Report FDA Received Date: 03/08/2018
• Supplement Report FDA Received Date: 05/01/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1