MAUDE Adverse Event Report: NULL; MIDLINE CATHETER

Device Problem Material Fragmentation (1261)

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

Event Date 05/25/2021

Event Type  Injury  

Event Description

Information was received indicating that a smiths medical iv catheter was being removed by nurse, catheter broke off in patients arm requiring removal by vascular surgeon.There were no other reported adverse events.

Manufacturer Narrative

This remediation mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).A manufacturing device history review (dhr) was not performed because the results of the complaint investigation do not indicate a problem with the manufacture of the device.No causes or potential causes of the customer's reported problem were found during the review of service and repair records.One used catheter assembly, with severed catheter tube, without needle guard assembly, sheath component and blister packaging, was returned for analysis.Magnified examination of the catheter assembly and severed catheter tube displayed evidence of bevel tip damage and a puncture in the catheter tube at the point of severance consistent with the v shape profile of the introducer needle with no evidence of tube tears within the catheter hub.This v shape incisions in the catheter tube length and catheter bevel tip are consistent with catheter wall penetrations by the cannula as a result of multiple redirects during insertion and not the result of a manufacturing nonconformance.In addition, the catheter tube displayed external damage at the point of severance consistent with a clamp or similar gripping device, highly probable to have occurred after catheter severance.Examination of the photos of the catheter assembly against the technical report for investigation into causes of catheter severance failure modes suggests the reinsertion of the needle into the catheter sheared and or punctured the catheter tubing.Based on device analysis, the root cause of the reported event was determined to be due to a variation in insertion technique.No actions will be taken at this time.

• Type of Device: MIDLINE CATHETER
• Manufacturer (Section G): NULL
• MDR Report Key: 12202672
• MDR Text Key: 264938469
• Report Number: 3012307300-2021-07439
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 71 YR
• Patient Sex: Male
• Patient Weight: 65 KG