MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRAIN,WOUND,19FR,1/4,FULL-FLUTED

Catalog Number DYNJWE2190

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

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

Event Date 02/17/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a clinician was performing a bedside procedure for a post-op patient with a drain that slipped out after having drains sutured in place intraoperatively.The patient underwent a liposuction and breast lift procedure and had drains placed post-surgery in the left and the right abdomen.According to the report, after approximately 1-2 hours, the patient stood up post op and the drains slipped from position almost immediately leaving approximately 1-2 inches of drain still in the patient.The clinician was able to give the patient lidocaine locally and the drains were slid back up into the surgical site.After the drains were reinserted no additional incidents were noted.The patient is now recovering as expected.No sample is not available to be returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that a drain that slipped out after having drains sutured in place intraoperatively requiring the drain to be reinserted.

• Type of Device: DRAIN,WOUND,19FR,1/4,FULL-FLUTED
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 11391928
• MDR Text Key: 234097917
• Report Number: 1417592-2021-00029
• Device Sequence Number: 1
• Product Code: GBX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJWE2190
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2021
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention