MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. DELTEC PROPORT IMPLANTABLE PORT; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number	21-4153-24
Medical Device Problem Codes	Material Fragmentation (1261); Detachment of Device or Device Component (2907); Filtration Problem (2941)
Health Effect - Clinical Code	Discomfort (2330)
Date of Event	11/06/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It was noted that the maintenance and cleaning of the catheter is done with serum and syringes of 5cc.
Event or Problem Description
Information was received that a smiths medical deltec proport implantable port had a filtration issue during chemotherapy treatment and required a catheter change.It was reported the patient experienced discomfort and while attempting to remove the catheter, the surgeon noted the base of the reservoir was detached.Subsequently, the patient needed surgical intervention to remove the device.No additional adverse patient effects were reported.
Additional Manufacturer Narrative
Chemotherapy dates were provided: (b)(6) 2018.
Event or Problem Description
Additional information was received on 11-22-2018, including the event date, patient information, concomitant therapy dates, date of installation was reported as (b)(6) 2018.
Additional Manufacturer Narrative
Device evaluation: one deltec proport implantable port was received in used condition without the original packaging.Four photographs were also received for evaluation.Upon immediate visual inspection, the following information was noted: the insert was loose and it can remove from the housing; the septum was collocated in the right position, but it does not exceeds the surface of the housing.No marks of the detached of weld were detected inside the housing nor around the inner side of the insert.The photographs also were examined and demonstrated that the insert is not flat with the housing, it is detached.Additionally, two of the photos show the front side of the port and that the septum is under the edge of the housing.Eight additional deltec ports from the same product stores were assembled using different techniques in order to reproduce the observed issue.From this testing, the investigation determined that the condition of the sample device was consistent with the port not having been welded during the assembly process, and the affected device was not detected during final inspection.A review of the manufacturing process was conducted and was considered adequate and correct.A dhr review was also completed with no discrepancies.Based on the evidence and testing, the complaint was confirmed.Manufacturing was noted to the event problem source.

• Brand Name: DELTEC PROPORT IMPLANTABLE PORT
• 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: 8053120
• Report Number: 3012307300-2018-08130
• Device Sequence Number: 19238801
• Product Code: LJT
• UDI-Device Identifier: 10610586012563
• UDI-Public: 10610586012563
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K994216
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/27/2019

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: 05/18/2022
• Device Catalogue Number: 21-4153-24
• Device Lot Number: 87X140
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2018
• Supplement Date Received by Manufacturer: 11/22/2018; 02/25/2019
• Initial Report FDA Received Date: 11/08/2018
• Supplement Report FDA Received Date: 12/21/2018; 03/27/2019
• 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
• Patient Age: 56 YR