MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC® PORT-A-CATH® POWER P.A.C; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4473-24
Medical Device Problem Code	Device Misassembled During Manufacturing /Shipping (2912)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/06/2017
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pre-attached deltec® port-a-cath® power p.A.C.Was assembled in reverse.The increments started at 70 at port instead of 10.Surgeon implanted one port and cut the catheter too short because of the catheter being reversed.The patient had to return to surgery for the port to be explanted.No permanent injury was reported.
Additional Manufacturer Narrative
One sample was received for investigation.Through visual inspection, it was confirmed that the printing on the catheter was inverted.Manufacturing processes and documentation was received.As the likely root cause was determined to be improper printing that went undetected, the manufacturing procedure was updated to include a visual inspection of the printing.

• Brand Name: DELTEC® PORT-A-CATH® POWER P.A.C
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 6966332
• Report Number: 3012307300-2017-02287
• Device Sequence Number: 19134923
• Product Code: LJT
• UDI-Device Identifier: 10610586032752
• UDI-Public: 10610586032752
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 03/15/2022
• Device Catalogue Number: 21-4473-24
• Device Lot Number: 87X095
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2017
• Supplement Date Received by Manufacturer: 06/14/2018
• Initial Report FDA Received Date: 10/20/2017
• Supplement Report FDA Received Date: 07/12/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention