MAUDE Adverse Event Report: HEALTH LINE INTERNATIONAL CORPORATION; MIDLINE CATHETER IN MIDLINE KIT

Catalog Number DYNJ80141MB

Device Problems Break (1069); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/12/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that immediately after insertion, the confused patient self-extracted the midline catheter (taken from the midline kit).The midline catheter was reportedly protected through a securement device and a transparent occlusive dressing.The midline catheter broke at the catheter securement junction with some part of the midline catheter remaining external to the patient.It was reported that the retained broken midline catheter was successfully removed and another midline catheter was successfully placed.There was no serious injury reported related to this event.Due to the reported event and the reported medical intervention, this medwatch is being filed.The sample is not available to be returned for evaluation.Pictures were provided for review and the complaint was confirmed.The manufacturer of the midline catheter has been notified of this incident.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that immediately after insertion, the confused patient self-extracted the midline catheter (taken from the midline kit).The broken midline catheter was successfully removed and another midline catheter was successfully placed.

• Type of Device: MIDLINE CATHETER IN MIDLINE KIT
• Manufacturer (Section D): HEALTH LINE INTERNATIONAL CORPORATION; 5675 w 300 s; salt lake city, UT 84104
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8847174
• MDR Text Key: 162645898
• Report Number: 1417592-2019-00130
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 07/31/2019

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 Catalogue Number: DYNJ80141MB
• Device Lot Number: 19EDD255
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/16/2019
• Initial Date FDA Received: 07/31/2019
• 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