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

Catalog Number	21-4482-24
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Report source: country of origin: (b)(6) age at time of event, date of birth: pediatric patient.
Event or Problem Description
It was reported that following implant of this deltec® port® power p.A.C.Ii, the catheter was found to be leaking, requiring surgical intervention.Upon implant, multiple needle pricks were made.Subsequently, a leak was observed 2 cm from the tip.The device was explanted and replaced with another device, causing a delay in chemotherapy.No permanent injury was reported.
Additional Manufacturer Narrative
It was initially reported that the implant date was (b)(6) 2017.The implant date is unknown.
Additional Manufacturer Narrative
One port was returned for analysis in used condition.Visual inspection of the catheter and the port noted no holes or damages.The catheter was in two parts, one part was attached on the "tube outlet".Functional testing included testing the sample with water in order to detect for leaks; no leak was found on the catheter or the port.A review of the manufacturing process was conducted and was considered adequate and correct.Based on the evidence, the complaint was not confirmed.The probable root cause was attributed to the product potentially being received damaged from the supplier, being damaged during the manufacturing process by coming into contact with a sharp edge, or the product being damaged when it left the manufacturing site.
Additional Manufacturer Narrative
This is a correction for the investigation report found in supplemental 2.The investigaton was approved after supplemental 2 was submitted.Correction: there is no root cause for this event since the complaint was not confirmed.

• Brand Name: DELTEC® PORT® POWER P.A.C. II
• 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: 6804982
• Report Number: 3012307300-2017-01838
• Device Sequence Number: 1116574
• Product Code: LJT
• UDI-Device Identifier: 10610586032769
• UDI-Public: 10610586032769
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K072657
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Device Explanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 05/15/2018

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: No Information
• Device Expiration Date: 11/01/2020
• Device Catalogue Number: 21-4482-24
• Device Lot Number: 3080359
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2017
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 07/31/2017; 02/14/2018; 04/27/2018
• Initial Report FDA Received Date: 08/18/2017
• Supplement Report FDA Received Date: 09/15/2017; 02/26/2018; 05/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CHEMOTHERAPY
• Outcome Attributed to Adverse Event: Required Intervention