MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. UNSPECIFIED DELTEC PORT-A-CATH¿; PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Infection (4544)

Event Date 12/01/2023

Event Type  Injury  

Event Description

It was reported that during the post procedure, an infection in the patient was discovered around the port site and around the catheter in the jugular vein.The catheter was found to have discolored to brown when removed from the vein.The patient was given an unspecified treatment for inflammation and was relieved after the treatment.There was patient involvement and patient harm/adverse event reported.This complaint was created to capture the 1st of 4 related incidents.

Manufacturer Narrative

Unknown manufacturer: a catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, smiths medical corporate headquarters in oakdale, mn has been listed in sections d3.And g1.And the oakdale fda registration number has been used for the manufacture report number.B3.Date of event: year of event has been provided, but month and day are unknown.D4.Lot number, expiration date, udi, and h4.Manufacture date are unknown; no information has been provided to date.Other operator of device: operator of device is unknown.H3.Reason device not evaluated by mfg: other; device was not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed.No product lot number was provided, therefore, no review of manufacturing device history records could be conducted.Based on the available information, the reported issue could not be confirmed and no root cause could be found.No actions have been taken.If the product is returned, the manufacturer will reopen this complaint for further investigation.

• Brand Name: UNSPECIFIED DELTEC PORT-A-CATH¿
• Type of Device: PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 3350 granada ave n, suite 100; oakdale MN 55128
• Manufacturer Contact: reed covert ; 6000 nathan lane n; minneapolis, MN 55442 ; 2247062300
• MDR Report Key: 18759403
• MDR Text Key: 336008740
• Report Number: 2183161-2024-00158
• Device Sequence Number: 1
• Product Code: LJT
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/24/2024
• Initial Date FDA Received: 02/22/2024
• Supplement Dates Manufacturer Received: 01/24/2024
• Supplement Dates FDA Received: 03/21/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention