MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; EVACUATOR,400CC,PVC,10FR,1/8"

Catalog Number DYNJWE402

Device Problems Break (1069); Entrapment of Device (1212)

Patient Problem Foreign Body In Patient (2687)

Event Date 03/19/2021

Event Type  Injury  

Manufacturer Narrative

It was reported that a patient had a drain in place for approximately 3 days (anatomical location of the drain unknown) and when the drain was being removed a 4 cm piece of the drain broke off inside of the patient.The piece of the drain was intentionally left inside of the patient and no intervention was performed to attempt to remove the broken piece of drain.There was an x-ray and a ct scan performed with no significant findings reported.No known impact to patient or staff.No known impact to the surgical procedure.The physician's assistant discarded the remaining broken portion of the drain at the patient's bedside and no sample will be returned to the manufacturer for evaluation.There was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.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 piece of the drain broke off inside of the patient while the drain was being removed.No medical intervention was performed and the drain fragment remains in the patient.

• Type of Device: EVACUATOR,400CC,PVC,10FR,1/8"
• 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: 11571575
• MDR Text Key: 242389893
• Report Number: 1417592-2021-00054
• Device Sequence Number: 1
• Product Code: GCY
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 03/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJWE402
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/19/2021
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 71 YR
• Patient Weight: 98