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

Model Number 21-4155-24

Device Problems Decoupling (1145); Connection Problem (2900)

Patient Problems Extravasation (1842); Patient Problem/Medical Problem (2688)

Event Type  Injury  

Event Description

It was reported that upon administration of the chemotherapy, filtration and extravasation (damage to the tissue) occurred.The operator suspected that there was a structural failure form the base of the reservoir (easily decouples).The operator stopped using the catheters, and peripheral routes were administered in order to deliver the remaining volume of treatment.The previous catheters were left in place however.No further complications were reported in relation to this event.

• Brand Name: DELTEC PROPORT PORTS
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC; 6000 nathan lane north; minneapolis, mn
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC; 3350 granada avenue north; suite 100; oakdale, mn
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, mn
• MDR Report Key: 9728783
• MDR Text Key: 180791194
• Report Number: 3012307300-2020-01424
• Device Sequence Number: 1
• Product Code: LJT
• UDI-Device Identifier: 10610586012594
• UDI-Public: 10610586012594
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994216
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/19/2020

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
• Device Operator: Health Professional
• Device Expiration Date: 12/05/2023
• Device Model Number: 21-4155-24
• Device Catalogue Number: 21-4155-24
• Device Lot Number: 3736572
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 02/19/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/16/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention