MAUDE Adverse Event Report: ST PAUL DELTEC LOGICATH CONVENTIONAL - ADULT; CENTRAL VENOUS CATHETERS

Lot Number 4012891

Device Problem Difficult to Advance (2920)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/10/2021

Event Type  malfunction  

Event Description

It was reported that while using the device, it contacted the distal end and prevented the adequate passage of the dilator.No patient injury was reported.

Manufacturer Narrative

Operator of device are unknown.No information is provided to date.For investigation no sample or pictures were provided.Therefore a complete investigation could not be performed.Based on the above information it is felt that this incident is not due to a product failure of the catheter or guide wire.A device history record (dhr) review was conducted which indicated all inspections were completed and no issues were noted during manufacture.This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms#(b)(4).

• Brand Name: DELTEC LOGICATH CONVENTIONAL - ADULT
• Type of Device: CENTRAL VENOUS CATHETERS
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 15433267
• MDR Text Key: 306276496
• Report Number: 3012307300-2022-19334
• Device Sequence Number: 1
• Product Code: PEZ
• Combination Product (y/n): N
• Reporter Country Code: CO
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 4012891
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/09/2022
• Initial Date FDA Received: 09/15/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/14/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female