MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; DRAIN,FLAT,HUBLESS,SILICONE,7MM,FULL,

Catalog Number DYNJWE1310

Device Problem Inaccurate Flow Rate (1249)

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

Event Date 09/16/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported; on (b)(6) 2020, a perforated hubless flat silicone wound drain had been placed on (b)(6) 2020 intraoperatively into a (b)(6) year-old female patient.On (b)(6) 2020 upon removal of the drain only part of the drain was removed.A cat scan was completed that same day ((b)(6) 2020) which revealed a retained portion of the catheter tubing in the fascia.Patient was taken to the operating room and the catheter tubing was removed.Reporter states, it is not known how the patient is doing at this time.There are no photos for submission and the sample is not available for return and evaluation.Therefore, a root cause will is unable to be determined.Due to the reported nature of this incident and medical intervention, a medwatch will be filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported upon removal of a perforated hubless flat silicone wound drain only part of the drain was removed.Ct scan revealed the remainder of the tubing in the fascia.

Manufacturer Narrative

Corrected data: lot numbers added to section d 4 (incorrect information removed).

Event Description

It was reported upon removal of a perforated hubless flat silicone wound drain only part of the drain was removed.Ct scan revealed the remainder of the tubing in the fascia.

• Type of Device: DRAIN,FLAT,HUBLESS,SILICONE,7MM,FULL,
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 10649936
• MDR Text Key: 244561867
• Report Number: 1417592-2020-00109
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYNJWE1310
• Device Lot Number: P2004288 AND P1935082
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Weight: 90