MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; CLOSUREFAST PROCEDURE PACK-LF

Catalog Number DYNJ0365463J

Device Problem Break (1069)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

According to the customer, on (b)(6) 2024 the 20 ml syringe was "broken upon opening the pack".The customer reported a replacement device was used to complete the procedure.To date, no information has been received to indicate that a user or a patient experienced a death, serious injury, medical intervention, follow-up care, or other adverse health impact associated with the reported problem/issue.In an abundance of caution, and in response to an fda 483 issued for cfn (b)(4) on 22-jan-2024, this medwatch is being filed for the reported problem/issue.If additional relevant information becomes available a supplemental medwatch will be filed.

Event Description

According to the customer, on (b)(6) 2024 the 20 ml syringe was "broken upon opening the pack".

• Type of Device: CLOSUREFAST PROCEDURE PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: danielle tognocchi ; three lakes drive; northfield, IL 60093
• MDR Report Key: 19004552
• MDR Text Key: 338930628
• Report Number: 1423395-2024-00376
• Device Sequence Number: 1
• Product Code: FDE
• UDI-Device Identifier: 40193489783873
• UDI-Public: 40193489783873
• 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: Other
• Type of Report: Initial
• Report Date: 03/29/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: DYNJ0365463J
• Device Lot Number: 23LMG882
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/01/2024
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other