MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; LAPAROSCOPIC PACK

Model Number DYNJ40413D

Device Problem Material Separation (1562)

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

Event Date 09/07/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported by (b)(6) hospital on (b)(6) 2020 a cotton tip, from a cotton tip applicator separated from the stick and became retained in a patient during a surgical procedure.The reporter states, the patient was a (b)(6) year-old male gunshot wound (gsw) patient undergoing a diagnostic laparoscopy to rule out internal injury secondary to the gunshot wound to the abdomen.Reporter states, "resident used cotton tipped applicator supplied in the pack to probe gsw tract through abdomen.Once cotton tipped applicator was removed, scrub noted the cotton tip was missing.Upon further inspection, all 12 cotton tip applicator tips removed with little effort." surgeon attempted to retrieve cotton tip with blind sweep with finger to no avail.Then attempts by same surgeon to wash out cotton tip using approximately 300 ml sterile saline, again to no avail.Reporter states, surgeon then "opted to make a two inch incision at end of tract to retrieve cotton tip.Once opened, she was unable to find cotton tip.She washed incision and tract with an additional 500 ml sterile saline.She then closed incision and removed trocars and closed trocar sites." reporter states, no serious injury has occurred due to this reported incident.However, due to the reported medical intervention and in abundance of caution a medwatch is being filed.Patient was discharged home on (b)(6) 2020 in stable condition.There are no samples available for return and evaluation.No further information is available.If additional relevant information becomes available, this report will be re-opened and re-evaluated.

Event Description

It was reported the cotton tip separated from the stick portion of a cotton tip applicator and was retained in a trauma patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: LAPAROSCOPIC PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: teresa maynard ; three lakes drive; northfield, IL 60093-2753 ; 2249311514
• MDR Report Key: 10619987
• MDR Text Key: 213920627
• Report Number: 1423395-2020-00025
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 10889942532995
• UDI-Public: 10889942532995
• 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,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: DYNJ40413D
• Device Catalogue Number: DYNJ40413D
• Device Lot Number: 20GBC737
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/08/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR