MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; HOOK, VARADY, PHLEBO, ROUNDED HOOK, 7"

Catalog Number MDS9283002

Device Problems Break (1069); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by south shore vein center, that a double-ended phlebectomy extractor failed during normal use of a vein extraction.The reporter states that on (b)(6) 2020, during an ambulatory phlebectomy procedure the hook of the extractor broke off into a (b)(6) male patients left leg.Reporter states, "was able to visualize the part and grasp with forceps and remove from the body." report confirms no serious injury or follow-up care required and reports the patient is doing "very well, with no complications." photos have been received and a root cause has yet to be determined.No further information is available at this time.Due to the nature of the reported incident, this medwatch is being filed.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported a double-ended phlebectomy extractor failed during normal use of a vein extraction.A piece broke off inside the patient's body and had to be retrieved.

Event Description

It was reported a double-ended phlebectomy extractor failed during normal use of a vein extraction.A piece broke off inside the patient's body and had to be retrieved.

Manufacturer Narrative

D9 device available for evaluation: yes, date returned to manufacturer: 10/28/2020.G6 type of report: follow-up.H3 device evaluated by manufacturer - yes, evaluation summary attached.H10 investigation report reads as follows, 11/13/2020, medline quality received one sample of mds9283002 with the lot 132348b19 for evaluation.It was reported that the hook broke during use.This concern was logged as qa 200410735."the reported concern was confirmed.At this time, it is unknown what could have caused this issue to occur.Our manufacturing site has been notified of the issue.".

• Type of Device: HOOK, VARADY, PHLEBO, ROUNDED HOOK, 7"
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10816168
• MDR Text Key: 219521656
• Report Number: 1417592-2020-00121
• Device Sequence Number: 1
• Product Code: GAI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 11/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MDS9283002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2020
• Date Manufacturer Received: 10/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 46 YR
• Patient Weight: 82