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

Model Number	21-4153-24
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Two pictures were received.In one of the photographs, it can be observed that the insert is not flat with the housing and it can see the insert detached from the housing.Relevant documents and the manufacturing process were reviewed; no discrepancies noted.The ultrasonic weld operation, performance of visual inspection, and set-up of ultrasonic welder were all reviewed; no discrepancies found.An audit of 32 units was performed to verify that all ports were welded; no discrepancies.Destructive testing was performed on 8 units that had been assembled; no discrepancies observed.Based on the evidence, the complaint was confirmed.The root cause was found due to the manufacturing process.
Event or Problem Description
Information was received indicating that upon removal of a smiths medical deltec proport port from a patient, problem at the level of the reservoir was noted.It was reported that injury occurred due to the need for extraction of the reservoir.Subsequently, the port was removed, discarded, and replaced with another.There were no further adverse effects.

• Brand Name: DELTEC
• Common Device Name: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD; INC.; 6000 nathan lane n; minneapolis, mn
• MDR Report Key: 9990136
• Report Number: 3012307300-2020-03187
• Device Sequence Number: 17194293
• 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: 2020
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/22/2020

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/09/2024
• Device Model Number: 21-4153-24
• Device Catalogue Number: 21-4153-24
• Device Lot Number: 3829676
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/23/2020
• 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