MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP; DBD-PLASTIC PACK-LF

Model Number DYNJ0781642P

Device Problem Contamination (1120)

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

Event Date 01/03/2020

Event Type  malfunction  

Event Description

It was reported that a hair was found wrapped around the syringe component.

Manufacturer Narrative

It was reported that a hair was found wrapped around the syringe component when the surgical pack was opened.No death, serious injury, medical intervention, follow-up care, or other adverse patient/health impact has been reported to the manufacturer.The surgical pack was returned for evaluation a long piece of black hair was confirmed to be wrapped where a user's fingers would be placed and the barrel of the syringe.The root cause has been determined to likely be due to a supplier product issue.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available, a supplemental medwatch will be filed.

• Type of Device: DBD-PLASTIC PACK-LF
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP; three lakes drive; northfield IL 60093 2753
• Manufacturer Contact: nigel vilches ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 18659869
• MDR Text Key: 334769541
• Report Number: 1423395-2024-00012
• Device Sequence Number: 1
• Product Code: FTN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: DYNJ0781642P
• Device Lot Number: 19JMB133
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2020
• Initial Date Manufacturer Received: 01/03/2020
• Initial Date FDA Received: 02/07/2024
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other